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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ligator, Hemorrhoidal
510(k) Number K882297
Device Name 1/2 CM REAR TIP EXTENDER (RTE)
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 Number876.4400
Classification Product Code
FHN  
Date Received06/02/1988
Decision Date 06/17/1988
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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