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510(k) K900442

Device
BURNS CASUALTY SHEET BURN ROLL
Applicant
PILGRIM MEDICAL SERVICES
510(k) number
K900442
Product code
FPY  
Decision
Substantially Equivalent (SESE)
Decision date
1990-07-03
Date received
1990-01-30
Regulation
880.5180
Classification name
Sheet, Burn
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BROWN
Address
The Old Coach House Chapel Rd., Rotherwas, Hereford England Hr2 6sx GB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FPY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K930759CP & S STERILE BURN SHEETConsolidated Products & Services, Inc.1994-01-21
K926290BURN SHEETGam Industries, Inc.1993-04-20
K921471BURNSHIELD TRAUMA DRESSINGLevtrade Intl. (Pty) , Ltd.1993-04-20
K921470BURNSHIELD FIRE BLANKETLevtrade Intl. (Pty) , Ltd.1993-04-20
K900443BURNS CASUALTY SHEET LIMB WRAPPilgrim Medical Services1990-07-03
K900441BURNS CASUALTY SHEETPilgrim Medical Services1990-07-03
K871740LYOSHEET SURGICAL SHEET FOR BURNSAcme United Corp.1987-06-09
K853145KENDALL CURITY BURN PADThe Kendal Co.1985-08-30
K841898FIRST RESPONSE EMERG. MEDICSL - BURNSReed Products, Inc.1984-08-14
K820994ABSORB FURN SHEETAmerican Convertors Div., American Pharmaseal1982-05-13
K800064WATER JEL FIRE BLANKETTrilling Resources, Ltd.1980-03-25
K792433TEMPORARY BURN SHEET WITH PERFORATEDAmerican Medical Disposable, Inc.1979-12-20
K792432TEMPORARY BURN SHEET WITH PERFORATEDAmerican Medical Disposable, Inc.1979-12-20
K780418BURN DRESSING PADThe Owenby Co.1978-04-10
K760210BLANKET, WATER-JEL FIREAmerican Safety1976-08-11

Legacy Summary#

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FDA Review#

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