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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 K153496
Device Name Disposable Surgical Face Mask
Applicant
Xiantao Rayxin Medical Products Co., Ltd.
# 258 Pengchang Rd., Middle St.
Xiantao,  CN 433018
Applicant Contact Liang Zhang
Correspondent
Beijing Believe Tech.Service Co., Ltd.
1-202, Build 3, Beijing New World, #5 Chaoyang Rd.
Chaoyang District
Beijing,  CN 100024
Correspondent Contact RAY WANG
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/07/2015
Decision Date 06/15/2016
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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