UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER— 510(k) K902585

Name: FDA 510(k) clearance K902585
Creator: U.S. Food and Drug Administration
Published: 1990-08-27

Substantially Equivalent

Advanced Surgical Intervention, Inc.

FDA 510(k) clearance K902585 for UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER, Substantially Equivalent on 1990-08-27. Applicant: Advanced Surgical Intervention, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Surgical Intervention, Inc.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1990-06-12
Decision date: 1990-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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