ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2— 510(k) K790519
Substantially EquivalentAmerican Medical Systems, Inc.
FDA 510(k) clearance K790519 for ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2, Substantially Equivalent on 1979-05-14. Applicant: American Medical Systems, Inc..
Clearance details
- Applicant
- American Medical Systems, Inc.
- Product code
- Code FAP
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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