The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Vasovasostomy Set.
| Device ID | K921546 |
| 510k Number | K921546 |
| Device Name: | VASOVASOSTOMY SET |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Tammy Bacon |
| Correspondent | Tammy Bacon COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-01 |
| Decision Date | 1993-07-02 |