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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 K920551
Device Name 120 FR OPTILUME PROSTATE BALLOON DILATOR
Applicant
American Medical Systems, Inc.
11001 Bren Rd. E.
Minnetonka,  MN  55343
Applicant Contact SUSAN TESMER
Correspondent
American Medical Systems, Inc.
11001 Bren Rd. E.
Minnetonka,  MN  55343
Correspondent Contact SUSAN TESMER
Regulation Number876.5520
Classification Product Code
KOE  
Date Received02/06/1992
Decision Date 10/28/1992
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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