FDA.reportPublic FDA data

510(k) K912520

Device
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
Applicant
3M HEALTH CARE, LTD.
510(k) number
K912520
Product code
KGX  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-26
Date received
1991-06-06
Regulation
880.5240
Classification name
Tape And Bandage, Adhesive
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HIRTE
Address
3m Center, Bldg. 275-3e-08 P.O. Box 33275 St. Paul MN US 55133 55133

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KGX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.2000-06-21
K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.1999-02-17
K972914SYVEK PATCHMarine Polymer Technologies, Inc.1997-12-22
K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.1996-01-17
K952606TARGETT PATCHCutting Edge Technologies, Inc.1995-12-21
K954007PARALLELJohnson & Johnson Consumer Products, Inc.1995-11-22
K944587DERMIVIEW HYPOALLERGENIC CLEAR TAPEJohnson & Johnson Medical, Inc.1995-10-30
K944588STERILE PLASTIC DRESSINGSmith & Nephew, Inc.1994-11-07
K940536BAND-AID(TM) BRAND ADHESIVE BANDAGEJohnson & Johnson Consumer Products, Inc.1994-10-03
K941788BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIPJohnson & Johnson Consumer Products, Inc.1994-10-03
K940798SHIPPERT PRESSURE BANDAGEDenver Splint Co.1994-09-28
K941389EMPI TAPE PATCHESEmpi1994-08-23
K942383DERMIVIEW CLEAR TAPEJohnson & Johnson International1994-08-22
K940378COVERLET ADHESIVE DRESSINGBeiersdorf, Inc.1994-07-29
K941499KIT PAK DRESSING CHANGE TRAYKit Pak, Inc.1994-07-20

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