FDA.reportPublic FDA data

510(k) K984207

Device
SILVERLON DIRECT PRESSURE WOUND DRESSING
Applicant
Argentum International, LLC
510(k) number
K984207
Product code
KMF
Decision
Substantially Equivalent (SESE)
Decision date
2007-03-19
Date received
1998-11-24
Regulation
880.5090
Classification name
Bandage, Liquid
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
A. BART FLICK
Address
P.O. Box 429 Lakemont GA US 30552 30552

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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