The following data is part of a premarket notification filed by Spectrascience, Inc. with the FDA for Spectra Science Biopsy Forceps.
| Device ID | K963517 |
| 510k Number | K963517 |
| Device Name: | SPECTRA SCIENCE BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | SPECTRASCIENCE, INC. 5909 BAKER ROAD, SUITE 580 Minnetonka, MN 55345 |
| Contact | Brian Mcmahon |
| Correspondent | Brian Mcmahon SPECTRASCIENCE, INC. 5909 BAKER ROAD, SUITE 580 Minnetonka, MN 55345 |
| Product Code | FCL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-12-02 |
| Summary: | summary |