The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for The Artificial Urinary Sphincter.
| Device ID | K821627 |
| 510k Number | K821627 |
| Device Name: | THE ARTIFICIAL URINARY SPHINCTER |
| Classification | Prosthesis, Urethral Sphincter |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FAG |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-02 |
| Decision Date | 1982-08-10 |