510(k) K821627
- Device
- THE ARTIFICIAL URINARY SPHINCTER
- Applicant
- AMERICAN MEDICAL SYSTEMS, INC.
- 510(k) number
- K821627
- Product code
- FAG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-10
- Date received
- 1982-06-02
- 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
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3013960851
- 3013987875
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FAG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K912934 | AMS SPHINCTER 800 URINARY PROSTHESIS | American Medical Systems, Inc. | 1992-03-18 |
Legacy Summary#
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FDA Review#
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