FDA.reportPublic FDA data

510(k) K933689

Device
MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING
Applicant
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
510(k) number
K933689
Product code
KMF  
Decision
Substantially Equivalent (SESE)
Decision date
1993-12-13
Date received
1993-07-29
Regulation
880.5090
Classification name
Bandage, Liquid
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHN J VOZELLA
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 KMF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241916TearRepair Liquid Skin ProtectantOptmed, Inc.2024-09-27
K182733Rochal Bioshield Silicone FilmRochal Industries, LLC2019-06-27
K171148Aleo BME Liquid BandageAleo Bme, Inc.2018-01-12
K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare2016-08-23
K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC2016-07-26
K131384KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGEKericure, Inc.2014-08-07
K133443MARATHON NO STING LIQUID SKIN PROTECTANTAdvanced Medical Solutions (Plymouth), Ltd.2014-07-10
K120059LIQUID BANDAGEChesson Laboratory Associates, Inc.2012-05-17
K092712SKIN BARRIER FILMLodestar Products, Inc.2010-02-23
K083087ECOCELPolichem S.A2009-08-07
K083913CHESSON LABS LIQUID BANDAGEChesson Laboratory Associates, Inc.2009-07-31
K083752GLUSEAL 90, MODEL GLU9010Glustitch, Inc.2009-02-23
K082703MRDH BANDAGEMarine Polymer Technologies, Inc.2008-10-14
K081009NEUTROPHASENovabay Pharmaceuticals2008-05-20
K073663GELSPRAY WOUND DRESSINGBiocure, Inc.2008-01-30

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