The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Williams Penile Anesthetic Retainer.
| Device ID | K896160 |
| 510k Number | K896160 |
| Device Name: | WILLIAMS PENILE ANESTHETIC RETAINER |
| Classification | Clamp, Penile |
| 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 | FHA |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-24 |
| Decision Date | 1990-02-16 |