The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Disposable Biopsy Forceps.
| Device ID | K950636 |
| 510k Number | K950636 |
| Device Name: | OLYMPUS DISPOSABLE BIOPSY FORCEPS |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-13 |
| Decision Date | 1995-02-27 |