ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2— 510(k) K790519

Name: FDA 510(k) clearance K790519
Creator: U.S. Food and Drug Administration
Published: 1979-05-14

Substantially Equivalent

American 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.. Device class: 2.

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1979-03-16
Decision date: 1979-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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