The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Fd-5 Hot Biopsy Forceps.
| Device ID | K951445 |
| 510k Number | K951445 |
| Device Name: | OLYMPUS FD-5 HOT BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Barry Sands |
| Correspondent | Barry Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-29 |
| Decision Date | 1995-05-03 |