Dripride Disposable Underpads

FDA 510(k) K871725 · Weyerhaeuser Co.

Substantially Equivalent

510(k) numberK871725

Submission

Device name
Dripride Disposable Underpads
Applicant
Weyerhaeuser Co.
Tacoma, WA, US
Received
May 4, 1987
Decision date
May 15, 1987
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

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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
K883895Dripride Ultra Incontinent PadEYQ · Traditional 01/30/1989SE
K883894Dripride Provide SlimEYQ · Traditional 01/30/1989SE
K881859Dripride Disposable UnderpadKME · Traditional 06/03/1988SE
K872059Dripride Provide UltraEYQ · Traditional 03/16/1988SE
K854408Adult Absorbent Incontinent BriefEYQ · Traditional 11/19/1985SE
K834359Absorbent Incontinent Pads & BriefsEYQ · Traditional 03/05/1984SE
K831593Maxi ShieldsHHD · Traditional 08/12/1983SE
K830224Unscented Panty ShieldsHHD · Traditional 02/08/1983SE
K812577Unscented Menstrual PadsHHD · Traditional 10/19/1981SE

Questions and answers

When was Dripride Disposable Underpads cleared by the FDA?

Dripride Disposable Underpads (K871725) received a 510(k) decision of Substantially Equivalent on May 15, 1987, 11 days after the submission was received.

What is the product code of K871725?

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