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510(k) K930457

Device
MEDIMAC BANDAGE
Applicant
ENQUAY PHARMACEUTICAL
510(k) number
K930457
Product code
KGX  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-25
Date received
1993-01-28
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

Related Records

Applicant Contact

Contact
BERNARD KOROL
Address
2840 NW 2nd Ave. Suite 213 Boca Raton FL US 33431 33431

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KGX  

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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