Cleared Traditional

K844602 - SCENTED MENSTRUAL PAD
(FDA 510(k) Clearance)

Jan 1985
Decision
50d
Days
Class 1
Risk

K844602 is an FDA 510(k) clearance for the SCENTED MENSTRUAL PAD. This device is classified as a Pad, Menstrual, Unscented (Class I - General Controls, product code HHD).

Submitted by Procter & Gamble Mfg. Co. (Cincinnati, US). The FDA issued a Cleared decision on January 16, 1985, 50 days after receiving the submission on November 27, 1984.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5435. 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..

Submission Details

510(k) Number K844602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date January 16, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary

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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