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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 K120181
Models AD1001G, AD1002G
Device Name LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
Original Applicant
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
5 carey street
pennington,  NJ  08534
Original Contact chengyu shen
Classification Product Code
FRO  
Date Received01/20/2012
Decision Date 02/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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