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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 K210304
Device Name Surgical Mask
Applicant
Jin Pin Electrical Co., Ltd. Zhuhai S.E.Z.
# 1 Shuanglin E. Rd., Da Lin Shan, Liangang Industrial
Park, Jinwan District
Zhuhai,  CN 519090
Applicant Contact Rongfeng Yu
Correspondent
Shanghai Sungo Management Consulting Company Limited.
Rm. 1309, Dongfang Bldg., 1500# Century Ave.,
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/03/2021
Decision Date 05/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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