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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 K201517
Device Name Plain Surgical Mask
Applicant
Aok Tooling Limited
#8, Longtian 3rd, Longtian St., Pingshan Dist.
Shenzhen,  CN 518122
Applicant Contact Francis Nithyananthan
Correspondent
Aok Tooling Limited % Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/08/2020
Decision Date 09/04/2020
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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