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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Basket, Ureteral, Metal
510(k) Number K972091
Device Name AMS FOREIGN BODY EXTRATOR
Applicant
American Medical Systems, Inc.
10700 Bren Rd. W.
Minnetonka,  MN  55343
Applicant Contact LISA L PRITCHARD
Correspondent
American Medical Systems, Inc.
10700 Bren Rd. W.
Minnetonka,  MN  55343
Correspondent Contact LISA L PRITCHARD
Regulation Number876.4680
Classification Product Code
FFL  
Date Received06/04/1997
Decision Date 08/29/1997
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
Predetermined Change
Control Plan Authorized		 No
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