Cleared Traditional

CAREFREE(TM) FESTIVA PANTYSHIELDS

K901664 · Personal Products Co. · Obstetrics & Gynecology

Jun 1990

Decision

73d

Days

Class 1

Risk

About This 510(k) Submission

K901664 is an FDA 510(k) clearance for the CAREFREE(TM) FESTIVA PANTYSHIELDS, 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 June 22, 1990, 73 days after receiving the submission on April 10, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.

Submission Details

510(k) Number	K901664 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 1990
Decision Date	June 22, 1990
Days to Decision	73 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.