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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K051059
Device Name AMSURE 100% SILICONE FOLEY CATHETER
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
EZL  
Date Received04/26/2005
Decision Date 06/28/2005
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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