The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Fb Series Biopsy Forceps.
| Device ID | K955065 |
| 510k Number | K955065 |
| Device Name: | OLYMPUS FB SERIES BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FCL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-06 |
| Decision Date | 1996-01-24 |