FDA.reportPublic FDA data

510(k) K040517

Device
TENDERWET ACTIVE
Applicant
MEDLINE INDUSTRIES, INC.
510(k) number
K040517
Product code
MGQ  
Decision
Substantially Equivalent (SESE)
Decision date
2004-03-25
Date received
2004-02-27
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
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
ANDREA HAFERKAMP
Address
One Medline Pl. Mundelein IL US 60060 60060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MGQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171879HylaGuard Moisturizing CreamFounders Science Group, LLC2017-10-16
K083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical Incorporated2009-03-27
K041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.2005-07-19
K041268SILVERSITE OR CALGITROLAdri2004-09-20
K040019SILVERSEALNoble Fiber Technologies2004-07-23
K022587MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGSMedtrade Products , Ltd.2003-08-22
K024367SINCLAIR WOUND AND SKIN EMULSIONSinclair Pharmaceuticals, Ltd.2003-07-28
K024054XYLOS XCELL ANTIMICROBIAL DRESSINGXylos Corporation2003-03-07
K022584CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSINGCardiotech Intl.2002-12-30
K022995COLLATEK HYDROGELBiocore Medical Technologies, Inc.2002-12-02
K013525CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)Coloplast Corp.2002-10-04
K020325L.A.M. IPM WOUND GELL.A.M. Pharmaceutical, Corp.2002-04-15
K011994ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101Acrymed, Inc.2001-11-08
K010583AMBU GEL, HYDROGEL BURN DRESSINGAmbu, Inc.2001-05-25
K002666DIAMOND ALOE VERA, STERILEMedi-Tech Intl. Corp.2001-02-27

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