Cleared Traditional

VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS

K981953 · Paragon Trade Brands, Inc. · Obstetrics & Gynecology

Aug 1998

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K981953 is an FDA 510(k) clearance for the VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Paragon Trade Brands, Inc. (Allendale, US). The FDA issued a Cleared decision on August 18, 1998, 76 days after receiving the submission on June 3, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K981953 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 1998
Decision Date	August 18, 1998
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

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.