Aero Chrome* Breathable Performance Surgical Gown

Gown, Surgical

Halyard Health, Inc.

The following data is part of a premarket notification filed by Halyard Health, Inc. with the FDA for Aero Chrome* Breathable Performance Surgical Gown.

Pre-market Notification Details

Device IDK153255
510k NumberK153255
Device Name:Aero Chrome* Breathable Performance Surgical Gown
ClassificationGown, Surgical
Applicant Halyard Health, Inc. 5405 Windward Parkway Alpharetta,  GA  30004
ContactDavid M. Lee
CorrespondentDavid M. Lee
Halyard Health, Inc. 5405 Windward Parkway Alpharetta,  GA  30004
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-10
Decision Date2016-04-13
Summary:summary

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