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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K852389
Device Name URETERAL STENT
Applicant
American Medical Systems, Inc.
11001 Bren Rd. E.
Minnetonka,  MN  55343
Applicant Contact MARK E MCINTYRE
Correspondent
American Medical Systems, Inc.
11001 Bren Rd. E.
Minnetonka,  MN  55343
Correspondent Contact MARK E MCINTYRE
Regulation Number876.4620
Classification Product Code
FAD  
Date Received06/05/1985
Decision Date 09/05/1985
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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