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510(k) K162930

Aero Chrome* Select Breathable Performance Surgical Gowns by Halyard Health, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2017
Date Received
October 19, 2016
Clearance Type
Traditional
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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