AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER

Catheter, Retention Type, Balloon

AMSINO INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsure 3-way Hydrophilic Latex Foley Catheter.

Pre-market Notification Details

Device IDK101824
510k NumberK101824
Device Name:AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
ClassificationCatheter, Retention Type, Balloon
Applicant AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. Pomona,  CA  91767
ContactJesus Farinas
CorrespondentJesus Farinas
AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. Pomona,  CA  91767
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-01
Decision Date2010-09-13
Summary:summary

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