The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Accent Dg Balloon Urteral Dilator Set, 10cm.
| Device ID | K915392 |
| 510k Number | K915392 |
| Device Name: | ACCENT DG BALLOON URTERAL DILATOR SET, 10CM |
| Classification | Dilator, Catheter, Ureteral |
| 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 | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-03-18 |