FDA.reportPublic FDA data

510(k) K994339

Device
HYCURE ORAL / HYCURE ORAL SMART GEL
Applicant
THE HYMED GROUP CORP.
510(k) number
K994339
Product code
KGN  
Decision
Substantially Equivalent (SESE)
Decision date
2000-03-22
Date received
1999-12-23
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound, Collagen
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANITA M PETITO
Address
1890 Bucknell Dr. Bethlehem PA US 18015 18015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KGN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260596Collagen Wound PowderVentris Medical2026-07-02
K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.2026-06-24
K253521ECMT-100 WMDEcm Therapeutics, Inc.2026-06-18
K253204CatalyzeBioTissue Holdings, Inc.2026-06-05
K254034Roosin Collagen PowderRoosin Medical Co., Ltd.2026-06-03
K253974Roosin Collagen DressingRoosin Medical Co., Ltd.2026-06-03
K261224MatriDermMedskin Solutions Dr. Suwelack AG2026-05-14
K260532Derma-GideGeistlich Pharma AG2026-03-19
K260218LacertaMatrixLacerta Life Sciences2026-02-19
K253140CollOvine™ Wound PowderOvigenex, LLC2026-02-10
K251323Device 104 ParticulateGeistlich Pharma AG2026-01-22
K253339TheracorStimlabs, LLC2025-12-22
K252673LacertaMatrixLacerta Life Science2025-12-22
K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG2025-12-19
K242100SurgiAid Collagen Wound Dressing (HA)Maxigen Biotech, Inc.2025-10-16

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