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510(k) K230838

Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets by Cardinal Health200, LLC — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2023
Date Received
March 27, 2023
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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