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510(k) K210860

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 by Gri-Alleset, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2022
Date Received
March 23, 2021
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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