LUOFUCON Silicone Ag Foam Dressing

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 Luofucon Silicone Ag Foam Dressing.

Pre-market Notification Details

Device IDK160022
510k NumberK160022
Device Name:LUOFUCON Silicone Ag Foam Dressing
ClassificationDressing, Wound, Drug
Applicant HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. NORTH SHANGXIA ROAD DONGJIANG HI-TECH INDUSTRY PARK Huizhou,  CN 516005
ContactGuosheng Tan
CorrespondentGuosheng Tan
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. NORTH SHANGXIA ROAD DONGJIANG HI-TECH INDUSTRY PARK Huizhou,  CN 516005
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2016-01-05
Decision Date2016-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00714196932730 K160022 000
04063591428208 K160022 000
04063591428246 K160022 000
04063591428291 K160022 000
04063591428321 K160022 000
04063591428376 K160022 000
00714196391025 K160022 000
00714196391049 K160022 000
00714196391063 K160022 000
00714196492203 K160022 000
00714196494504 K160022 000
00714196496607 K160022 000
00714196932723 K160022 000
00324357020444 K160022 000

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