Modess* Beltless Feminine Napkin

FDA 510(k) K781470 · Personal Products Co.

Substantially Equivalent

510(k) numberK781470

Submission

Device name
Modess* Beltless Feminine Napkin
Applicant
Personal Products Co.
Mchenry, IL, US
Received
August 28, 1978
Decision date
September 7, 1978
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.

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K062796K-Y Brand IntrigueNUC · Traditional 12/08/2006SE
K010365Ortho Control Female Urinary Control DeviceMNG · Traditional 04/30/2001SE
K990536O.B. TamponHEB · Traditional 08/31/1999SE
K991118O.B. Applicator Tampons, O.B. TamponsHEB · Traditional 06/29/1999SE
K974629O.B. Applicator and Non-Applicator TamponsHEB · Traditional 02/10/1998SE
K971589Reach Antibacterial ToothbrushEFW · Traditional 07/24/1997SE
K970954O.B. Applicator TamponsHEB · Traditional 06/10/1997SE
K961119Carefree PantylinersHHL · Traditional 04/17/1996SE
K953638O.B. Applicator TamponsHIL · Traditional 10/20/1995SE

Questions and answers

When was Modess* Beltless Feminine Napkin cleared by the FDA?

Modess* Beltless Feminine Napkin (K781470) received a 510(k) decision of Substantially Equivalent on September 7, 1978, 10 days after the submission was received.

What is the product code of K781470?

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