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510(k) K180874

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield by 3M Healthcare — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2018
Date Received
April 3, 2018
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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