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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 K202096
Device Name 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On
Applicant
EcoGuard Inc.
700 S Battleground Ave., Suite 103
Grover,  NC  28073
Applicant Contact Fang Wang
Correspondent
mdi Consultants, Inc.
55 Northern Blvd, Suite 200
Great Neck,  NY  11021
Correspondent Contact Nickita Alexiades
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/29/2020
Decision Date 02/02/2021
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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