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510(k) K201470

Disposable Medical Face Mask by Jkh USA, LLC — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2020
Date Received
June 3, 2020
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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