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510(k) K970266

Device
KENDALL HYDROPHILIC POWDER WOUND DRESSING
Applicant
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
510(k) number
K970266
Product code
KGN  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1997-04-23
Date received
1997-01-23
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
Third party reviewed
No

Applicant Contact#

Contact
DAVID A OLSON
Address
15 Hampshire St. Mansfield MA US 02048 02048

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
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
K252001Collagen Wound DressingWinner Medical Co., Ltd.2025-10-10
K250397Helios Dermal ScaffoldHelios Biomedical, Inc.2025-08-15
K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited2025-07-16

Legacy Summary#

summary

FDA Review#

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