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510(k) K202899

Procedure Mask, Surgical Mask by Kenpax International Limited — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2021
Date Received
September 29, 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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