Cleared Traditional

SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD

K895519 · Personal Products Co. · Obstetrics & Gynecology

Nov 1989

Decision

78d

Days

Class 1

Risk

About This 510(k) Submission

K895519 is an FDA 510(k) clearance for the SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD, 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 November 29, 1989, 78 days after receiving the submission on September 12, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.

Submission Details

510(k) Number	K895519 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 1989
Decision Date	November 29, 1989
Days to Decision	78 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.