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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, catheter, ureteral
510(k) Number K940542
Device Name NAMIC ARIA(TM) INFLATION DEVICE
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
11001 BREN RD. EAST
MINNETONKA,  MN  55343
Applicant Contact ANGELA RAULN
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
11001 BREN RD. EAST
MINNETONKA,  MN  55343
Correspondent Contact ANGELA RAULN
Regulation Number876.5470
Classification Product Code
EZN  
Date Received02/07/1994
Decision Date 04/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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