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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 K101824
Device Name AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
Applicant
AMSINO INTERNATIONAL, INC.
855 TOWNE CENTER DR.
POMONA,  CA  91767
Applicant Contact JESUS FARINAS
Correspondent
AMSINO INTERNATIONAL, INC.
855 TOWNE CENTER DR.
POMONA,  CA  91767
Correspondent Contact JESUS FARINAS
Regulation Number876.5130
Classification Product Code
EZL  
Date Received07/01/2010
Decision Date 09/13/2010
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
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