-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WljVqHdiITA+KC/jHTiyAH3AMd0/8gQMR1goQsStzlKbRs+LmZnxv676wL0HpfSO DU97WGLcKGu9MocN4tpK4g== 0000897101-96-001082.txt : 19961218 0000897101-96-001082.hdr.sgml : 19961218 ACCESSION NUMBER: 0000897101-96-001082 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19961216 ITEM INFORMATION: Other events FILED AS OF DATE: 19961217 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: SPECTRASCIENCE INC CENTRAL INDEX KEY: 0000727672 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 411448837 STATE OF INCORPORATION: MN FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-13092 FILM NUMBER: 96681854 BUSINESS ADDRESS: STREET 1: 5909 BAKER ROAD SUITE 580 CITY: MINNEAPOLIS STATE: MN ZIP: 55345 BUSINESS PHONE: 612-931-90 MAIL ADDRESS: STREET 1: 5909 BAKER RD, STE 580 STREET 2: 5909 BAKER RD, STE 580 CITY: MINNETONKA STATE: MN ZIP: 55345 FORMER COMPANY: FORMER CONFORMED NAME: GV MEDICAL INC DATE OF NAME CHANGE: 19920703 8-K 1 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of Earliest Event Reported): December 16, 1996 SPECTRASCIENCE, INC. (Exact Name of Registrant as Specified in its Charter) Minnesota 0-13092 41-1448837 (State or Other Jurisdiction (Commission (IRS Employer of Incorporation File Number) Identification Number) 3650 Annapolis Lane, Suite 101, Minneaplis, Minnesota 55447 (Address of Principal Executive Offices) Registrant's Telephone Number, Including Area Code: (612) 509-9999 ITEM 5. Other Events. On December 16, 1996, SPECTRASCIENCE, Inc. announced that it received 510(k) premarket notification clearance from the United States Food and Drug Administration for its fiberoptic Biopsy Forceps. Details of this announcement are included in the attached Press Release dated December 16, 1996. Signature Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. SPECTRASCIENCE, Inc. By /s/ CHING-MENG CHEW Ching-Meng Chew Vice President Finance & Administration Chief Financial Officer Dated: December 17, 1996 EX-99 2 PRESS RELEASE SPECTRASCIENCE, Inc. For more information please contact: 3650 Annapolis Lane, Suite 101 Brian T. McMahon, President & CEO Minneapolis, MN 55447 Ching-Meng Chew, Vice President & CFO Telephone: (612) 509-9999 FOR IMMEDIATE RELEASE SPECTRASCIENCE RECEIVES 510(k) PREMARKET NOTIFICATION CLEARANCE FROM UNITED STATES FOOD AND DRUG ADMINISTRATION FOR FIBEROPTIC BIOPSY FORCEPS - ------------------------------------------------------------------------------- MINNEAPOLIS, December 16, 1996 -- SPECTRASCIENCE, Inc. (NASDAQ: SPSI) announced today that the Company has been notified by the United States Food and Drug Administration that it has received 510(k) premarket notification clearance for its fiberoptic Biopsy Forceps. The SPECTRASCIENCE Biopsy Forceps is designed specifically to collect tissue samples utilizing minimally invasive endoscopic techniques for histopathological examination. The disposable product is intended for endoscopic gastrointestinal and urological biopsy applications. The SPECTRASCIENCE Biopsy Forceps has an adjunctive feature incorporating a fiberoptic core for the transmission of light during tissue biopsy procedures. The Biopsy Forceps will be utilized during clinical studies to further advance the development of the electro-optic and software components of the SPECTRASCIENCE Optical BiopsyTM System. SPECTRASCIENCE believes that achievement of this significant milestone is an important step towards the clinical development of its Optical Biopsy(TM) System and the generation of revenues worldwide through institutional sales of its products. SPECTRASCIENCE is a market driven early growth stage company located in Minneapolis, Minnesota, which applies advanced spectroscopic diagnostic techniques to the analysis of specific human tissues associated with important diseases. The Company believes its technology will significantly impact the medical market, initially in cardiovascular medicine and the detection of cancer. # # # # -----END PRIVACY-ENHANCED MESSAGE-----