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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 K202843
Device Name Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)
Applicant
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
Floor 3, Bldg. 1, 28 Huoju St., Changping S & T Park,
Changping District
Beijing,  CN 102200
Applicant Contact Jiahui Li
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/25/2020
Decision Date 01/12/2021
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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