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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Urethral
510(k) Number K900761
Device Name AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
Applicant
American Medical Systems, Inc.
11001 Bren Rd. E.
Minnetonka,  MN  55343
Applicant Contact DENNIS TOUSSAINT
Correspondent
American Medical Systems, Inc.
11001 Bren Rd. E.
Minnetonka,  MN  55343
Correspondent Contact DENNIS TOUSSAINT
Regulation Number876.5520
Classification Product Code
KOE  
Date Received02/16/1990
Decision Date 05/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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