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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 K211249
Device Name Altor Safety 3-Ply Surgical Mask (Model:62222)
Applicant
Altor Safety LLC
711 Executive Boulevard Suite C
Valley Cottage,  NY  10989
Applicant Contact Jared Scott
Correspondent
Thomas Regulatory Resolutions, Inc.
1069 Piccadilly St.
Palm Beach Gardens,  FL  33418
Correspondent Contact Dallas L. Thomas
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/26/2021
Decision Date 07/23/2021
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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