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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K172963
Device Name Master-Frank N95 Particulate Respirator
Applicant
Master & Frank Enterprise Co., Ltd.
Banhu Industrial District
Dong Duan,  CN 523000
Applicant Contact Shuge Zhao
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Rm. 1122, # 55 Shizhou Middle Rd.,
Nanshan District
Shenzhen,  CN GD755
Correspondent Contact Field Fu
Regulation Number878.4040
Classification Product Code
MSH  
Date Received09/26/2017
Decision Date 04/04/2018
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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