Cardinal Health Isolation Gown

Gown, Isolation, Surgical

Cardinal Health 200, LLC

The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Cardinal Health Isolation Gown.

Pre-market Notification Details

Device IDK160339
510k NumberK160339
Device Name:Cardinal Health Isolation Gown
ClassificationGown, Isolation, Surgical
Applicant Cardinal Health 200, LLC 1500 Waukegan Road Waukegan,  IL  60085
ContactCaroline Miceli
CorrespondentCaroline Miceli
Cardinal Health 200, LLC 1500 Waukegan Road Waukegan,  IL  60085
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-08
Decision Date2016-07-28
Summary:summary

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