The following data is part of a premarket notification filed by Biopsys Medical, Inc. with the FDA for Forceps.
| Device ID | K953962 |
| 510k Number | K953962 |
| Device Name: | FORCEPS |
| Classification | Forceps, General & Plastic Surgery |
| Applicant | BIOPSYS MEDICAL, INC. 27130 A PASEO ESPADA, SUITE 1424 San Juan Capistrano, CA 92675 |
| Contact | Mark A Cole |
| Correspondent | Mark A Cole BIOPSYS MEDICAL, INC. 27130 A PASEO ESPADA, SUITE 1424 San Juan Capistrano, CA 92675 |
| Product Code | GEN |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1995-09-08 |