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510(k) K120181

Device
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
Applicant
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
510(k) number
K120181
Product code
FRO  
Decision
Substantially Equivalent (SESE)
Decision date
2013-02-14
Date received
2012-01-20
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound, Drug
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHENGYU SHEN
Address
5 Carey St. Pennington NJ US 08534 08534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FRO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.2026-08-14
K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC2026-08-11
K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.2026-06-24
K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.2026-06-24
K261638Bonvadis®Oneness Biotech Co., Ltd.2026-06-17
K254073StatSeal DiscMerit Medical Systems, Inc.2026-05-13
K254191IWD-Gel™InnovaCorium, Inc.2026-04-07
K252023MiraChlor Antimicrobial Wound SolutionLetus Corporation2026-03-25
K251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH2026-03-13
K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd.2026-03-11
K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.2026-02-02
K252568New Day Skin SpraySilk Holdings, Inc.2026-01-23
K250890SBC1 CreamSioxmed, LLC2026-01-12
K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.2026-01-08
K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.2026-01-05

Legacy Summary#

summary

FDA Review#

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