Sanitary/Ob Pad

FDA 510(k) K792296 · American Hospital Supply Corp.

Substantially Equivalent

510(k) numberK792296

Submission

Device name
Sanitary/Ob Pad
Applicant
American Hospital Supply Corp.
Mchenry, IL, US
Received
November 13, 1979
Decision date
December 13, 1979
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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K854739American Sterile Surgical Absorbent Towel · Traditional 12/27/1985SE
K854759American Sterile Mayo Stand Tray · Traditional 12/17/1985SE
K832826Aap Dosimetry Release or Basin SetsFNY · Traditional 04/23/1984SE
K830546Dosimetric ReleaseKQT · Traditional 05/25/1983SE
K822990Convertors Primary Wound Dressing IIFRO · Traditional 04/12/1983SE
K830343Container W/Priming SolutionKDP · Traditional 03/17/1983SE
K830301Stratus Fluorometric Enzyme IMMUN0-JJE · Traditional 02/25/1983SE
K822755Latex Penrose Tubing · Traditional 01/21/1983SE
K823418Heyer-Schute Universal Ureteral StentLJE · Traditional 12/03/1982SE
K822966Convertors Disposable Dressing SpongeNAB · Traditional 11/05/1982SE

Questions and answers

When was Sanitary/Ob Pad cleared by the FDA?

Sanitary/Ob Pad (K792296) received a 510(k) decision of Substantially Equivalent on December 13, 1979, 30 days after the submission was received.

What is the product code of K792296?

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