ACUCISE URETERAL CUTTING CATHETER— 510(k) K921838

Name: FDA 510(k) clearance K921838
Creator: U.S. Food and Drug Administration
Published: 1993-02-26

Substantially Equivalent

Applied Urology, Inc.

FDA 510(k) clearance K921838 for ACUCISE URETERAL CUTTING CATHETER, Substantially Equivalent on 1993-02-26. Applicant: Applied Urology, Inc.. Device class: 2.

Clearance details

Applicant: Applied Urology, Inc.
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1992-04-17
Decision date: 1993-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Launa Hills, CA, US

Download summary PDF View on FDA.gov ↗

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