The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for 3 French Flexible Biopsy Forceps.
| Device ID | K881399 |
| 510k Number | K881399 |
| Device Name: | 3 FRENCH FLEXIBLE BIOPSY FORCEPS |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Frederick D Roemer |
| Correspondent | Frederick D Roemer COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-04-11 |