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510(k) K192374

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip by Cardinal Health200, LLC — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2019
Date Received
August 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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