The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Laparoscopic Mini Retractor Set.
| Device ID | K936026 |
| 510k Number | K936026 |
| Device Name: | COOK LAPAROSCOPIC MINI RETRACTOR SET |
| Classification | Coagulator, Culdoscopic (and Accessories) |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Rick Lykins |
| Correspondent | Rick Lykins COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | HFI |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-17 |
| Decision Date | 1994-03-11 |