Cleared Traditional

UNSCENTED MENSTRUAL PAD

K953633 · Tendasoft, Inc. · Obstetrics & Gynecology

Nov 1995

Decision

89d

Days

Class 1

Risk

About This 510(k) Submission

K953633 is an FDA 510(k) clearance for the UNSCENTED MENSTRUAL PAD, a Pad, Menstrual, Unscented (Class I — General Controls, product code HHD), submitted by Tendasoft, Inc. (Van Wert, US). The FDA issued a Cleared decision on November 1, 1995, 89 days after receiving the submission on August 4, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.

Submission Details

510(k) Number	K953633 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 1995
Decision Date	November 01, 1995
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement

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.