LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM

Dressing, Wound, Drug

HUIZHOU FORYOU MEDICAL DEVICES CO, LTD

The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co, Ltd with the FDA for Lufucon Silver Alginate Dressing 50x50mm, Lufucon Silver Alginate Dressing 100x100mm, Lufucon Silver Dressing 200x100mm.

Pre-market Notification Details

Device IDK120181
510k NumberK120181
Device Name:LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
ClassificationDressing, Wound, Drug
Applicant HUIZHOU FORYOU MEDICAL DEVICES CO, LTD 5 CAREY STREET Pennington,  NJ  08534
ContactChengyu Shen
CorrespondentChengyu Shen
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD 5 CAREY STREET Pennington,  NJ  08534
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2012-01-20
Decision Date2013-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00819123010670 K120181 000
00324357060228 K120181 000
00324357060457 K120181 000
00324357060662 K120181 000
00324357060884 K120181 000
00810040130670 K120181 000
00819123010687 K120181 000
00819123010694 K120181 000
10819123010547 K120181 000
10819123010561 K120181 000
10819123010530 K120181 000
00324357060129 K120181 000

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