FDA.report

510(k) K213598

Device
LUOFUCON Collagen Wound Dressing
Applicant
Huizhou Foryou Medical Devices Co., Ltd.
510(k) number
K213598
Product code
KGN
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-20
Date received
2021-11-15
Classification name
Wound Dressing With Animal-Derived Material(S)
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Taylor Deng
Address
#1 Shangxia N. Rd., Dongjiang Hi-Tech Industry Park, Huizhou CN 516000 516000

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K250397Helios Dermal ScaffoldHelios Biomedical, Inc.2025-08-15
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K250329GeniPhys Collymer Self-Assembling ScaffoldGeniphys, Inc.2025-06-25
K242985CollOvine™ Wound DressingOvigenex, LLC2025-06-20
K241904DermiSphere Dermal TemplateFesariustherapeutics, Inc.2025-01-06