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

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..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code KOE
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-06
Decision date: 1992-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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