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510(k) K210949

Device
Foundation Dermal Regeneration Scaffold (DRS) Solo
Applicant
Bionova Medical Inc.
510(k) number
K210949
Product code
FRO  
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-11
Date received
2021-03-30
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
Alex Greene
Address
3012 Centre Oak Way Suite 102 Germantown TN US 38138 38138

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#

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FDA Review#

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