Laurier Safety Long Sanitory Napkin

FDA 510(k) K852924 · Kao Corp.

Substantially Equivalent

510(k) numberK852924

Submission

Device name
Laurier Safety Long Sanitory Napkin
Applicant
Kao Corp.
Tokyo 103 Japan, JP
Received
July 9, 1985
Decision date
August 27, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HHD – Pad, Menstrual, Unscented
Device class
Class I (low risk)
Regulation
21 CFR 884.5435
Specialty
Obstetrics/Gynecology

An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.

Other 510(k)s with product code HHD

510(k)DeviceApplicantDecision
K071827Always Menstrual PadsHHD · Traditional Procter & Gamble, Inc.09/20/2007SE
K012629Always DuetsHHD · Traditional Procter & Gamble Co.10/05/2001SE
K003843Envive MiniformsHHD · Traditional Procter & Gamble Co.02/08/2001SE
K993870Unscented Interlabial Menstrual PadHHD · Traditional Procter & Gamble Co.01/18/2000SE
K980395Gladrags Cotton Menstrual PadHHD · Traditional Keepers!, Inc.04/16/1998SE
K953470Flushies Flushable/Biodegradable Menstrual Pads/Napkins (Ultra Thins)HHD · Traditional Mediquip, Inc.11/21/1995SE
K953668Unscented Ultrathin Maxi PadHHD · Traditional Paragon Trade Brands, Inc.11/01/1995SE
K953667Unscented Curved Ultrathin Maxi PadsHHD · Traditional Paragon Trade Brands, Inc.11/01/1995SE
K953633Unscented Menstrual PadHHD · Traditional Tendasoft, Inc.11/01/1995SE
K953553Unscented Menstral PadHHD · Traditional Paragon Trade Brands, Inc.10/27/1995SE

More from Paragon Trade Brands, Inc.

510(k)DeviceDecision
K893773Laurier Sanitary NapkinHHD · Traditional 08/11/1989SE
K882768Laurier Sanitary NapkinHHD · Traditional 08/05/1988SE
K872481Laurier Night Safe Extra Protection Sanitary Nap.HHD · Traditional 08/05/1987SE
K862269Laurier Santary Napkin (Modification)HHD · Traditional 07/30/1986SE
K862271Laurier Safety Long Sanitary Napkin (Modification)HHD · Traditional 07/07/1986SE
K862270Laurier Overnight Sanitary Napkin (Modification)HHD · Traditional 07/07/1986SE
K852922Laurier Overnight Sanitary NapkinHHD · Traditional 08/26/1985SE
K843318Laurier Sanitary NapkinHHD · Traditional 10/15/1984SE

Questions and answers

When was Laurier Safety Long Sanitory Napkin cleared by the FDA?

Laurier Safety Long Sanitory Napkin (K852924) received a 510(k) decision of Substantially Equivalent on August 27, 1985, 49 days after the submission was received.

What is the product code of K852924?

The FDA product code is HHD – Pad, Menstrual, Unscented, a Class I (low risk) device regulated under 21 CFR 884.5435.