AMSURE FOLEY INSERTION TRAY

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

AMSINO INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsure Foley Insertion Tray.

Pre-market Notification Details

Device IDK030664
510k NumberK030664
Device Name:AMSURE FOLEY INSERTION TRAY
ClassificationTray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Applicant AMSINO INTERNATIONAL, INC. 4501 BRICKELL PRIVADO ST. Ontario,  CA  91761
ContactChing Ching Seah
CorrespondentChing Ching Seah
AMSINO INTERNATIONAL, INC. 4501 BRICKELL PRIVADO ST. Ontario,  CA  91761
Product CodeFCM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-03
Decision Date2003-05-23

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