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510(k) K191355

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask by 3M Healthcare — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2019
Date Received
May 21, 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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