Cleared Traditional

MENSTRUAL TAMPON

K953333 · Paragon Trade Brands, Inc. · Obstetrics & Gynecology

Dec 1995

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K953333 is an FDA 510(k) clearance for the MENSTRUAL TAMPON, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Paragon Trade Brands, Inc. (Federal Way, US). The FDA issued a Cleared decision on December 6, 1995, 142 days after receiving the submission on July 17, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K953333 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 1995
Decision Date	December 06, 1995
Days to Decision	142 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.