Whenever Unscented Regular Thin Maxi-Pads

Q: What is the product code of K861355?

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

FDA 510(k) K861355 · Marcal Paper Mills, Inc.

Substantially Equivalent

510(k) numberK861355

Submission

Device name: Whenever Unscented Regular Thin Maxi-Pads
Applicant: Marcal Paper Mills, Inc.
Elmwood Park, NJ, US
Received: April 10, 1986
Decision date: April 23, 1986
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)	Device	Applicant	Decision
K071827	Always Menstrual PadsHHD · Traditional	Procter & Gamble, Inc.	09/20/2007SE
K012629	Always DuetsHHD · Traditional	Procter & Gamble Co.	10/05/2001SE
K003843	Envive MiniformsHHD · Traditional	Procter & Gamble Co.	02/08/2001SE
K993870	Unscented Interlabial Menstrual PadHHD · Traditional	Procter & Gamble Co.	01/18/2000SE
K980395	Gladrags Cotton Menstrual PadHHD · Traditional	Keepers!, Inc.	04/16/1998SE
K953470	Flushies Flushable/Biodegradable Menstrual Pads/Napkins (Ultra Thins)HHD · Traditional	Mediquip, Inc.	11/21/1995SE
K953668	Unscented Ultrathin Maxi PadHHD · Traditional	Paragon Trade Brands, Inc.	11/01/1995SE
K953667	Unscented Curved Ultrathin Maxi PadsHHD · Traditional	Paragon Trade Brands, Inc.	11/01/1995SE
K953633	Unscented Menstrual PadHHD · Traditional	Tendasoft, Inc.	11/01/1995SE
K953553	Unscented Menstral PadHHD · Traditional	Paragon Trade Brands, Inc.	10/27/1995SE

More from Paragon Trade Brands, Inc.

510(k)	Device	Decision
K901690	Whenever(R) Unscented Super Maxi PadHHD · Traditional	08/21/1990SE
K861357	Whenever Unscented Panty ShieldHHD · Traditional	04/23/1986SE
K861356	Whenever Unscented Super Thin Maxi-PadsHHD · Traditional	04/23/1986SE

Questions and answers

When was Whenever Unscented Regular Thin Maxi-Pads cleared by the FDA?

Whenever Unscented Regular Thin Maxi-Pads (K861355) received a 510(k) decision of Substantially Equivalent on April 23, 1986, 13 days after the submission was received.

What is the product code of K861355?

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