Burnshield Fire Blanket

FDA 510(k) K921470 · Levtrade Intl. (Pty) , Ltd.

Substantially Equivalent

510(k) numberK921470

Submission

Device name
Burnshield Fire Blanket
Applicant
Levtrade Intl. (Pty) , Ltd.
Petoria, South Africa, ZA
Received
March 27, 1992
Decision date
April 20, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FPY – Sheet, Burn
Device class
Class I (low risk)
Regulation
21 CFR 880.5180
Specialty
General Hospital

Other 510(k)s with product code FPY

510(k)DeviceApplicantDecision
K930759CP & S Sterile Burn SheetFPY · Traditional Consolidated Products & Services, Inc.01/21/1994SE
K926290Burn SheetFPY · Traditional Gam Industries, Inc.04/20/1993SE
K921471Burnshield Trauma DressingFPY · Traditional Levtrade Intl. (Pty) , Ltd.04/20/1993SE
K900443Burns Casualty Sheet Limb WrapFPY · Traditional Pilgrim Medical Services07/03/1990SE
K900442Burns Casualty Sheet Burn RollFPY · Traditional Pilgrim Medical Services07/03/1990SE
K900441Burns Casualty SheetFPY · Traditional Pilgrim Medical Services07/03/1990SE
K871740Lyosheet Surgical Sheet for BurnsFPY · Traditional Acme United Corp.06/09/1987SE
K853145Kendall Curity Burn PadFPY · Traditional The Kendal Co.08/30/1985SN
K841898First Response Emerg. Medicsl - BurnsFPY · Traditional Reed Products, Inc.08/14/1984SE
K820994Absorb Furn SheetFPY · Traditional American Convertors Div., American Pharmaseal05/13/1982SE

More from American Convertors Div., American Pharmaseal

510(k)DeviceDecision
K943728Burnfree Burnsoothe HydrogelMGQ · Traditional 09/27/1994SN
K943470Burnfree Burnsoothe Hydrogel Burn BlottsMGQ · Traditional 09/27/1994SN
K921471Burnshield Trauma DressingFPY · Traditional 04/20/1993SE

Questions and answers

When was Burnshield Fire Blanket cleared by the FDA?

Burnshield Fire Blanket (K921470) received a 510(k) decision of Substantially Equivalent on April 20, 1993, 389 days after the submission was received.

What is the product code of K921470?

The FDA product code is FPY – Sheet, Burn, a Class I (low risk) device regulated under 21 CFR 880.5180.