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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 K030120
Device Name AMSURE FOLEY CATHETER
Applicant
AMSINO INTERNATIONAL, INC.
4501 BRICKELL PRIVADO ST.
ONTARIO,  CA  91761
Applicant Contact CHING CHING SEAH
Correspondent
AMSINO INTERNATIONAL, INC.
4501 BRICKELL PRIVADO ST.
ONTARIO,  CA  91761
Correspondent Contact CHING CHING SEAH
Regulation Number876.5130
Classification Product Code
EZL  
Date Received01/13/2003
Decision Date 10/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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