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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 K091699
Device Name AMSURE 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 Received06/10/2009
Decision Date 08/10/2009
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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