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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K152544
Device Name Agem Ag Mesh Dressing with Silver
Applicant
Shenzhen Yuanxing Nano-Pharma Co., Ltd.
Rm. 1001, Resources-Tech-Bldg., No 1, Songpingshan Rd.,
Hi-Tech Industrial Park, Nanshan District
Shenzhen,  CN 518057
Applicant Contact LIU LONGQING
Correspondent
Shenzhen Hlongmed Biotech Company
R15-08, E. Bldg., Yihai Plz., Chuangye Rd.,
Nanshan District
Shenzhen,  CN 518054
Correspondent Contact LONG YANG
Classification Product Code
FRO  
Date Received09/04/2015
Decision Date 05/23/2016
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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