The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Silicone Rectal Balloon.
| Device ID | K930135 |
| 510k Number | K930135 |
| Device Name: | SILICONE RECTAL BALLOON |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Tammy Bacon |
| Correspondent | Tammy Bacon COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-12 |
| Decision Date | 1993-10-08 |