Cleared Traditional

TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATION

K891474 · Tambrands, Inc. · Obstetrics & Gynecology

Jun 1989

Decision

83d

Days

Class 1

Risk

About This 510(k) Submission

K891474 is an FDA 510(k) clearance for the TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATION, a Pad, Menstrual, Unscented (Class I — General Controls, product code HHD), submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on June 7, 1989, 83 days after receiving the submission on March 16, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.

Submission Details

510(k) Number	K891474 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 1989
Decision Date	June 07, 1989
Days to Decision	83 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.