Cleared Traditional

ALWAYS MENSTRUAL PADS

K071827 · Procter & Gamble, Inc. · Obstetrics & Gynecology
Sep 2007
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K071827 is an FDA 510(k) clearance for the ALWAYS MENSTRUAL PADS, a Pad, Menstrual, Unscented (Class I — General Controls, product code HHD), submitted by Procter & Gamble, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 20, 2007, 79 days after receiving the submission on July 3, 2007. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.

Submission Details

510(k) Number K071827 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2007
Decision Date September 20, 2007
Days to Decision 79 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HHD — Pad, Menstrual, Unscented
Device Class Class I — General Controls
CFR Regulation 21 CFR 884.5435
Definition 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.