Cleared Traditional

DEODORANT MAXI PAD

K962954 · Paragon Trade Brands, Inc. · Obstetrics & Gynecology

Oct 1996

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K962954 is an FDA 510(k) clearance for the DEODORANT MAXI PAD, a Pad, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HHL), submitted by Paragon Trade Brands, Inc. (Gaffney, US). The FDA issued a Cleared decision on October 10, 1996, 72 days after receiving the submission on July 30, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5425.

Submission Details

510(k) Number	K962954 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 1996
Decision Date	October 10, 1996
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement

Device Classification

Product Code	HHL — Pad, Menstrual, Scented, Scented-deodorized
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5425
Definition	Scented Or Scented-deodorized Menstrual Pads Used To Absorb Menstrual Or Other Vaginal Discharge, Including Those Intended As Intralabial Pads Or Reusable Menstrual Pads. These Are Made With Materials That Do Not Meet The Requirements For Class 1 Per 21 Cfr 884.5425(b).