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510(k) K210688

AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown by O&M Halyard, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2021
Date Received
March 8, 2021
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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