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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tray, catheterization, sterile urethral, with or without catheter (kit)
510(k) Number K082831
Device Name AMSELF CLOSED CATHETERIZATION SYSTEM
Applicant
AMSINO INTERNATIONAL, INC.
855 TOWNE CENTER DR.
POMONA,  CA  91767
Applicant Contact CHING CHING SEAH
Correspondent
AMSINO INTERNATIONAL, INC.
855 TOWNE CENTER DR.
POMONA,  CA  91767
Correspondent Contact CHING CHING SEAH
Regulation Number876.5130
Classification Product Code
FCM  
Date Received09/26/2008
Decision Date 10/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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