Auto Trauma Kit

FDA 510(k) K790411 · Marshall Electronics, Inc.

Substantially Equivalent

510(k) numberK790411

Submission

Device name
Auto Trauma Kit
Applicant
Marshall Electronics, Inc.
Mchenry, IL, US
Received
February 26, 1979
Decision date
June 1, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KME – Bedding, Disposable, Medical
Device class
Class I (low risk)
Regulation
21 CFR 880.6060
Specialty
General Hospital

Other 510(k)s with product code KME

510(k)DeviceApplicantDecision
K042145Ready-Heat BlanketKME · Traditional Techtrade, LLC09/17/2004SE
K944953Orex Medical BeddingKME · Traditional Thantex Specialties, Inc.12/02/1994SE
K933636Dispose-A-SheetKME · Traditional Belmac Healthcare Corp.01/26/1994SE
K932539Doctor Down --Rescue WrapKME · Traditional Three Dog Down11/02/1993SE
K922143American Burn SheetKME · Traditional American Silk Sutures, Inc.08/10/1992SE
K915303Foil Baby BuntingKME · Traditional Gam Industries, Inc.02/20/1992SE
K912257Chem-Sleeve BKME · Traditional Haz-Med, Inc.12/31/1991SE
K911953Medi Guard Sheets/UnderlaysKME · Traditional Sancella, Inc.05/28/1991SE
K911952Medi Guard UnderpadKME · Traditional Sancella, Inc.05/28/1991SE
K911948Medi Guard PillowcaseKME · Traditional Sancella, Inc.05/28/1991SE

More from Sancella, Inc.

510(k)DeviceDecision
K813247Kaneson/Comfort Plus Manual Breast PumpHGY · Traditional 12/03/1981SE
K780023Black Bag, ElectronicLDE · Traditional 02/21/1978SE

Questions and answers

When was Auto Trauma Kit cleared by the FDA?

Auto Trauma Kit (K790411) received a 510(k) decision of Substantially Equivalent on June 1, 1979, 95 days after the submission was received.

What is the product code of K790411?

The FDA product code is KME – Bedding, Disposable, Medical, a Class I (low risk) device regulated under 21 CFR 880.6060.