120 FR OPTILUME PROSTATE BALLOON DILATOR— 510(k) K920551

Name: FDA 510(k) clearance K920551
Creator: U.S. Food and Drug Administration
Published: 1992-10-28

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K920551 for 120 FR OPTILUME PROSTATE BALLOON DILATOR, Substantially Equivalent on 1992-10-28. 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: 1992-02-06
Decision date: 1992-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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