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510(k) K882558

Device
AREOLA/NIPPLE DRESSING
Applicant
COOPER SURGICAL/AESTHETE
510(k) number
K882558
Product code
FRO  
Decision
Substantially Equivalent (SESE)
Decision date
1989-05-24
Date received
1988-06-21
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#

Contact
THOMAS D SALISBURY
Address
Post Office Box 278 634 Airport Rd. Paso Robles CA US 93447 93447

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#

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FDA Review#

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