Cleared Traditional

UNSCENTED MENSTRUAL PADS

K880735 · Personal Products Co. · Obstetrics & Gynecology

Apr 1988

Decision

61d

Days

Class 1

Risk

About This 510(k) Submission

K880735 is an FDA 510(k) clearance for the UNSCENTED MENSTRUAL PADS, a Pad, Menstrual, Unscented (Class I — General Controls, product code HHD), submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on April 25, 1988, 61 days after receiving the submission on February 24, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.

Submission Details

510(k) Number	K880735 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 1988
Decision Date	April 25, 1988
Days to Decision	61 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.