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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K231005
Device Name Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
Applicant
Supermax Healthcare Canada-Supermax Medical
1001 Rue Jean-Talon Bureau 100
Saint-Bruno-De-Montarville,  CA J3V 0N3
Applicant Contact Nicolas Bergeron
Correspondent
Dicentra, Inc.
7 St. Thomas St., Unit 603
Toronto,  CA M5S 2B7
Correspondent Contact Alicja Wojewnik
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/07/2023
Decision Date 12/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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