FDA.reportPublic FDA data

510(k) K802017

Device
DRESSING CHANGE SET CAT.#910-930
Applicant
POLLAK (INTL.), LTD.
510(k) number
K802017
Product code
FRO  
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-10
Date received
1980-08-20
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
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
K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH2026-09-22
K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC2026-09-11
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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases