AMS OPTILUME(TM) PROSTATE BALLOON DILATOR— 510(k) K900761

Name: FDA 510(k) clearance K900761
Creator: U.S. Food and Drug Administration
Published: 1990-05-17

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K900761 for AMS OPTILUME(TM) PROSTATE BALLOON DILATOR, Substantially Equivalent on 1990-05-17. 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: 1990-02-16
Decision date: 1990-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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