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510(k) K935725

Device
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
Applicant
DEROYAL INDUSTRIES, INC.
510(k) number
K935725
Product code
KGX  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-04
Date received
1993-12-01
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
DEBRA F MANNING
Address
200 Debusk Ln. Powell TN US 37849 37849

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
K944588STERILE PLASTIC DRESSINGSmith & Nephew, Inc.1994-11-07
K941788BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIPJohnson & Johnson Consumer Products, Inc.1994-10-03
K940536BAND-AID(TM) BRAND ADHESIVE BANDAGEJohnson & 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#

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FDA Review#

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