Pelvic Exam Tray

FDA 510(k) K800874 · Pharmaseal Laboratories

Substantially Equivalent

510(k) numberK800874

Submission

Device name
Pelvic Exam Tray
Applicant
Pharmaseal Laboratories
Mchenry, IL, US
Received
April 17, 1980
Decision date
May 8, 1980
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
K800737Debrisan (Dextranomer) PasteKOZ · Traditional 08/04/1980SE
K801146Sampling KitCBT · Traditional 06/04/1980SE
K800362Fluid Dispensing SystemKYX · Traditional 03/12/1980SE
K760469Cleansing Agent, New Wound (Debrissu)KOZ · Traditional 12/16/1976SE

Questions and answers

When was Pelvic Exam Tray cleared by the FDA?

Pelvic Exam Tray (K800874) received a 510(k) decision of Substantially Equivalent on May 8, 1980, 21 days after the submission was received.

What is the product code of K800874?

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