First Response Emerg. Medicsl - Burns

FDA 510(k) K841898 · Reed Products, Inc.

Substantially Equivalent

510(k) numberK841898

Submission

Device name
First Response Emerg. Medicsl - Burns
Applicant
Reed Products, Inc.
Walker, MI, US
Received
May 7, 1984
Decision date
August 14, 1984
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

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
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
K820994Absorb Furn SheetFPY · Traditional American Convertors Div., American Pharmaseal05/13/1982SE

More from American Convertors Div., American Pharmaseal

510(k)DeviceDecision
K841900First Response Emerg. Eye InjuriesLRR · Traditional 07/23/1984SE
K841899First Response Emerg. Medical Sys BonesKGX · Traditional 07/23/1984SE
K841897First Response Emerg. Medical SystemKGX · Traditional 07/23/1984SE

Questions and answers

When was First Response Emerg. Medicsl - Burns cleared by the FDA?

First Response Emerg. Medicsl - Burns (K841898) received a 510(k) decision of Substantially Equivalent on August 14, 1984, 99 days after the submission was received.

What is the product code of K841898?

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