The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Circle Nephrostomy Catheter Set.
| Device ID | K961933 |
| 510k Number | K961933 |
| Device Name: | CIRCLE NEPHROSTOMY CATHETER SET |
| Classification | Catheter, Nephrostomy |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Rick Lykins |
| Correspondent | Rick Lykins COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-17 |
| Decision Date | 1996-07-18 |
| Summary: | summary |