510(k) K953553

UNSCENTED MENSTRAL PAD by Paragon Trade Brands, Inc. — Product Code HHD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 27, 1995
Date Received: July 28, 1995
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Pad, Menstrual, Unscented
Device Class: Class I
Regulation Number: 884.5435
Review Panel: OB
Submission Type

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.

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)
K962953 — DEODORANT PANTY SHIELD (October 10, 1996)
K962962 — DEODORANT PANTY LINER (October 10, 1996)
K953333 — MENSTRUAL TAMPON (December 6, 1995)
K953667 — UNSCENTED CURVED ULTRATHIN MAXI PADS (November 1, 1995)
K953668 — UNSCENTED ULTRATHIN MAXI PAD (November 1, 1995)
K953517 — UNSCENTED MENSTRUAL PAD (October 26, 1995)
K953700 — UNSCENTED CURVED MAXI PAD (September 27, 1995)

Other clearances for product code HHD

K071827 — ALWAYS MENSTRUAL PADS (September 20, 2007)
K012629 — ALWAYS DUETS (October 5, 2001)
K003843 — ENVIVE MINIFORMS (February 8, 2001)
K993870 — UNSCENTED INTERLABIAL MENSTRUAL PAD (January 18, 2000)
K980395 — GLADRAGS COTTON MENSTRUAL PAD (April 16, 1998)
K953470 — FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) (November 21, 1995)
K953668 — UNSCENTED ULTRATHIN MAXI PAD (November 1, 1995)
K953667 — UNSCENTED CURVED ULTRATHIN MAXI PADS (November 1, 1995)
K953633 — UNSCENTED MENSTRUAL PAD (November 1, 1995)
K953517 — UNSCENTED MENSTRUAL PAD (October 26, 1995)