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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 K170077
Device Name LUOFUCON Silicone Ag Foam Dressing with Border
Applicant
Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd. Dongjiang Hi-Tech Industry Park
Huizhou,  CN 516005
Applicant Contact Guosheng Tan
Correspondent
Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd. Dongjiang Hi-Tech Industry Park
Huizhou,  CN 516005
Correspondent Contact Guosheng Tan
Classification Product Code
FRO  
Date Received01/09/2017
Decision Date 03/30/2017
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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