The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Balloon (nephrostomy Tract) Dilation Catheter Set.
| Device ID | K891406 |
| 510k Number | K891406 |
| Device Name: | BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET |
| Classification | Catheter, Nephrostomy |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young 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 | 1989-03-14 |
| Decision Date | 1989-04-07 |