The following data is part of a premarket notification filed by Spectrascience, Inc. with the FDA for Spectrascience Reusable Biopsy Forceps.
| Device ID | K973611 |
| 510k Number | K973611 |
| Device Name: | SPECTRASCIENCE REUSABLE BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | SPECTRASCIENCE, INC. 3650 ANNAPOLIS LANE, SUITE 101 Minneapolis, MN 55447 -5434 |
| Contact | John G Yager |
| Correspondent | John G Yager SPECTRASCIENCE, INC. 3650 ANNAPOLIS LANE, SUITE 101 Minneapolis, MN 55447 -5434 |
| Product Code | FCL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-22 |
| Decision Date | 1997-12-02 |
| Summary: | summary |