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510(k) K944588

Device
Sterile Plastic Dressing
Applicant
SMITH & NEPHEW, INC.
510(k) number
K944588
Product code
KGX
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-07
Date received
1994-09-19
Regulation
880.5240
Classification name
Tape And Bandage, Adhesive
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEAN-PIERRE DESMARAIS
Address
2100, 52nd Ave., Lachine Quebec CA H8T 2Y5 H8T 2Y5

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
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
K941943SURGICAL ADHESIVE TAPERaleigh Lions Clinic For the Blind, Inc.1994-06-30