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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
510(k) Number K030664
Device Name AMSURE FOLEY INSERTION TRAY
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
FCM  
Date Received03/03/2003
Decision Date 05/23/2003
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
Predetermined Change
Control Plan Authorized		 No
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