SURESEAL ENDOSCOPIC VALVE— 510(k) K920030

Name: FDA 510(k) clearance K920030
Creator: U.S. Food and Drug Administration
Published: 1992-03-18

Substantially Equivalent

Applied Urology, Inc.

FDA 510(k) clearance K920030 for SURESEAL ENDOSCOPIC VALVE, Substantially Equivalent on 1992-03-18. Applicant: Applied Urology, Inc.. Device class: 2.

Clearance details

Applicant: Applied Urology, Inc.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1992-01-03
Decision date: 1992-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

Download summary PDF View on FDA.gov ↗

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