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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, electrosurgical, active, urological
510(k) Number K971512
Device Name AMS COAGULOOP RESECTION ELECTRODE
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Applicant Contact JOHN M OTTO
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Correspondent Contact JOHN M OTTO
Regulation Number876.4300
Classification Product Code
FAS  
Date Received04/28/1997
Decision Date 07/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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