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510(k) K242502

Aurelia Surgical Mask ASTM Level-3 (2130) by Supermax Healthcare Canada – Supermax Medical — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2024
Date Received
August 22, 2024
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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