AERO CHROME* Breathable Performance Surgical Gowns

Gown, Surgical

O&M Halyard, Inc

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

Pre-market Notification Details

Device IDK200522
510k NumberK200522
Device Name:AERO CHROME* Breathable Performance Surgical Gowns
ClassificationGown, Surgical
Applicant O&M Halyard, Inc 9120 Lockwood Blvd Mechanicsville,  VA  23116
ContactKimberly Lewis
CorrespondentKimberly Lewis
O&M Halyard, Inc 9120 Lockwood Blvd Mechanicsville,  VA  23116
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral Hospital
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-02
Decision Date2020-03-16

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