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510(k) K810902

Device
IP-758 BURN WOUND DRESSING
Applicant
EXOPACK
510(k) number
K810902
Product code
FRO  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-11
Date received
1981-04-03
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
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FRO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K252167Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)Qingdao Bright Moon Biomedical Materials Co., Ltd.2025-12-19
K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd.2025-11-19
K250115Hemastyl(™) Wound DressingRapid Nexus Nanotech Wound Solutions, Inc.2025-10-14
K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC2025-10-10
K243166DermalageInfection Elimination Solutions, LLC2025-08-27

Legacy Summary#

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FDA Review#

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