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510(k) K193327

Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve by Cardinal Health200, LLC — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2020
Date Received
December 2, 2019
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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