The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Balloon Dilation Catheter.
| Device ID | K896448 |
| 510k Number | K896448 |
| Device Name: | BALLOON DILATION CATHETER |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 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 | 1989-11-09 |
| Decision Date | 1990-03-07 |