The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Balloon Ureteral Dilators, Accent Dg Balloon Ureteral Dilator Set, Ascend Balloon Dilation Catheters, Balloon Dilation C.
| Device ID | K990072 |
| 510k Number | K990072 |
| Device Name: | BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Debbie Schmidt |
| Correspondent | Debbie Schmidt COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-11 |
| Decision Date | 1999-03-25 |
| Summary: | summary |