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 |