510(k) K962953

DEODORANT PANTY SHIELD by Paragon Trade Brands, Inc. — Product Code HHL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 10, 1996
Date Received: July 30, 1996
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Pad, Menstrual, Scented, Scented-Deodorized
Device Class: Class II
Regulation Number: 884.5425
Review Panel: OB
Submission Type

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).

Other clearances by Paragon Trade Brands, Inc.

K983381 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS (October 19, 1998)
K981953 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS (August 18, 1998)
K962954 — DEODORANT MAXI PAD (October 10, 1996)
K962962 — DEODORANT PANTY LINER (October 10, 1996)
K953333 — MENSTRUAL TAMPON (December 6, 1995)
K953668 — UNSCENTED ULTRATHIN MAXI PAD (November 1, 1995)
K953667 — UNSCENTED CURVED ULTRATHIN MAXI PADS (November 1, 1995)
K953553 — UNSCENTED MENSTRAL PAD (October 27, 1995)
K953517 — UNSCENTED MENSTRUAL PAD (October 26, 1995)
K953666 — UNSCENTED MENSTRAL PAD WITH WINGS (September 27, 1995)

Other clearances for product code HHL

K962962 — DEODORANT PANTY LINER (October 10, 1996)
K962954 — DEODORANT MAXI PAD (October 10, 1996)
K961119 — CAREFREE PANTYLINERS (April 17, 1996)
K913237 — ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD (September 23, 1991)
K913238 — ALWAYS, UNSCENTED MENSTRUAL PAD (September 23, 1991)
K891473 — TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO (June 7, 1989)
K890655 — NEW FREEDOM THIN DEODORANT MAXI PADS (May 1, 1989)
K884951 — TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT (January 10, 1989)
K884446 — MAXITHINS SUPER PADS, DEODORANT (December 20, 1988)
K884444 — MAXITHINS REGULAR PADS, DEODORANT (December 5, 1988)