Cleared Traditional

UNSCENTED INTERLABIAL MENSTRUAL PAD

K993870 · Procter & Gamble Co. · Obstetrics & Gynecology
Jan 2000
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K993870 is an FDA 510(k) clearance for the UNSCENTED INTERLABIAL MENSTRUAL PAD, a Pad, Menstrual, Unscented (Class I — General Controls, product code HHD), submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on January 18, 2000, 64 days after receiving the submission on November 15, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.

Submission Details

510(k) Number K993870 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1999
Decision Date January 18, 2000
Days to Decision 64 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.

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