ENTRAC URETHRAL BALLOON DILATATION CATHETER— 510(k) K920711

Name: FDA 510(k) clearance K920711
Creator: U.S. Food and Drug Administration
Published: 1992-05-06

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K920711 for ENTRAC URETHRAL BALLOON DILATATION CATHETER, Substantially Equivalent on 1992-05-06. Applicant: American Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-18
Decision date: 1992-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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