510(k) K912934
- Device
- AMS SPHINCTER 800 URINARY PROSTHESIS
- Applicant
- AMERICAN MEDICAL SYSTEMS, INC.
- 510(k) number
- K912934
- Product code
- FAG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-18
- Date received
- 1991-07-05
- Regulation
- 510(k) Premarket Notification
- Classification name
- Prosthesis, Urethral Sphincter
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Gastroenterology/Urology
- Device class
- 3
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- QUINLAN SMITH
- Address
- 11001 Bren Rd. E. Minnetonka MN US 55343 55343
FDA Registration Numbers#
- 3013960851
- 3013987875
Source Documents#
Other 510(k) Records For Product Code FAG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K821627 | THE ARTIFICIAL URINARY SPHINCTER | American Medical Systems, Inc. | 1982-08-10 |
Legacy Summary#
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FDA Review#
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