Molinea Underpads

FDA 510(k) K843402 · Paul Hartmann Corp.

Substantially Equivalent

510(k) numberK843402

Submission

Device name
Molinea Underpads
Applicant
Paul Hartmann Corp.
Mchenry, IL, US
Received
August 30, 1984
Decision date
September 7, 1984
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
K843405MolicareEYQ · Traditional 10/19/1984SE
K843404Molinea Incontinent PadEYQ · Traditional 10/19/1984SE
K843403Molinea PantyEYQ · Traditional 10/19/1984SE
K843401Ria Panty ShieldsHHD · Traditional 10/15/1984SE

Questions and answers

When was Molinea Underpads cleared by the FDA?

Molinea Underpads (K843402) received a 510(k) decision of Substantially Equivalent on September 7, 1984, 8 days after the submission was received.

What is the product code of K843402?

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