Blanket, Water-Jel Fire

FDA 510(k) K760210 · American Safety

Substantially Equivalent

510(k) numberK760210

Submission

Device name
Blanket, Water-Jel Fire
Applicant
American Safety
Walker, MI, US
Received
July 12, 1976
Decision date
August 11, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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K930759CP & S Sterile Burn SheetFPY · Traditional Consolidated Products & Services, Inc.01/21/1994SE
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K921471Burnshield Trauma DressingFPY · Traditional Levtrade Intl. (Pty) , Ltd.04/20/1993SE
K921470Burnshield Fire BlanketFPY · 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

More from Reed Products, Inc.

510(k)DeviceDecision
K790195Foot ValveGET · Traditional 02/26/1979SE

Questions and answers

When was Blanket, Water-Jel Fire cleared by the FDA?

Blanket, Water-Jel Fire (K760210) received a 510(k) decision of Substantially Equivalent on August 11, 1976, 30 days after the submission was received.

What is the product code of K760210?

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