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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 K141619
FOIA Releasable 510(k) K141619
Device Name LUOFUCON SILVER FOAM DRESSING
Applicant
Huizhou Foryou Medical Devices Co., Ltd.
853 Dorchester Ln., Unit-B
New Milford,  NJ  07646
Applicant Contact CHARLES SHEN
Correspondent
Huizhou Foryou Medical Devices Co., Ltd.
853 Dorchester Ln., Unit-B
New Milford,  NJ  07646
Correspondent Contact CHARLES SHEN
Classification Product Code
FRO  
Date Received06/17/2014
Decision Date 04/06/2015
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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