Cleared Traditional

UNSCENTED MENSTRUAL PAD

K864673 · Procter & Gamble Mfg. Co. · Obstetrics & Gynecology

Jan 1987

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K864673 is an FDA 510(k) clearance for the UNSCENTED MENSTRUAL PAD, a Pad, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HHL), submitted by Procter & Gamble Mfg. Co. (Cincinnati, US). The FDA issued a Cleared decision on January 21, 1987, 50 days after receiving the submission on December 2, 1986. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5425.

Submission Details

510(k) Number	K864673 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 1986
Decision Date	January 21, 1987
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—

Device Classification

Product Code	HHL — Pad, Menstrual, Scented, Scented-deodorized
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5425
Definition	Scented Or Scented-deodorized Menstrual Pads Used To Absorb Menstrual Or Other Vaginal Discharge, Including Those Intended As Intralabial Pads Or Reusable Menstrual Pads. These Are Made With Materials That Do Not Meet The Requirements For Class 1 Per 21 Cfr 884.5425(b).