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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 K213970
Device Name D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
Applicant
Danameco Medical Joint Stock Corporation
No 12, Trinh Cong Son St.
Da Nang,  VN 550000
Applicant Contact Huynh Thi Li Li
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/20/2021
Decision Date 01/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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