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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K091306
Device Name AMSURE PVC INTERMITTENT CATHETER
Applicant
AMSINO INTERNATIONAL, INC.
855 TOWNE CENTER DR.
POMONA,  CA  91767
Applicant Contact HOLIVEN JI
Correspondent
AMSINO INTERNATIONAL, INC.
855 TOWNE CENTER DR.
POMONA,  CA  91767
Correspondent Contact HOLIVEN JI
Regulation Number876.5130
Classification Product Code
EZD  
Date Received05/04/2009
Decision Date 08/21/2009
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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