Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve

Gown, 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 Chemoplus Full Coverage Gown, Closed Back, Cardinal Health Chemoplus Full Coverage Gown, Open Back, Cardinal Health Chemoplus Full Coverage Sleeve.

Pre-market Notification Details

Device IDK193327
510k NumberK193327
Device Name:Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
ClassificationGown, Surgical
Applicant Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan,  IL  60085
ContactCaroline Miceli
CorrespondentCaroline Miceli
Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan,  IL  60085
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-02
Decision Date2020-03-20

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