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510(k) K231005

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 by Supermax Healthcare Canada-Supermax Medical — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2023
Date Received
April 7, 2023
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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