The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook-vpi Continence Cuff.
| Device ID | K863227 |
| 510k Number | K863227 |
| Device Name: | COOK-VPI CONTINENCE CUFF |
| Classification | Clamp, Penile |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Gerald J French |
| Correspondent | Gerald J French COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | FHA |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-21 |
| Decision Date | 1987-02-03 |