510(k) K936189

PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED by Playtex Family Products, Inc. — Product Code HIL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 7, 1994
Date Received: December 27, 1993
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tampon, Menstrual, Scented, Scented-Deodorized
Device Class: Class II
Regulation Number: 884.5460
Review Panel: OB
Submission Type

A scented or scented-deodorized 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.

Other clearances by Playtex Family Products, Inc.

K941196 — PLATEX TAMPONS MODEL NUMBER 07094 (April 19, 1994)
K940821 — PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED (March 25, 1994)
K932909 — PLAYTEX ULTIMATES TAMPONS (March 7, 1994)
K932907 — PLAYTEX ULTIMATES TAMPONS (March 7, 1994)
K934083 — PLAYTEX ULTIMATES TAMPONS (March 7, 1994)
K935276 — PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS (March 7, 1994)
K922834 — TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY (September 1, 1993)
K924279 — PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER + (May 21, 1993)
K914438 — PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS (January 2, 1992)
K912002 — PLAYTEX NON-DEODORANT/DEODORANT TAMPONS (August 12, 1991)

Other clearances for product code HIL

K132208 — ONTEX AND OTHERS PROPRIETARY NAMES (April 10, 2014)
K132819 — PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (October 9, 2013)
K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (June 21, 2012)
K111684 — PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD (February 3, 2012)
K081555 — TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED (June 27, 2008)
K073662 — PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS (January 17, 2008)
K072376 — PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS (December 12, 2007)
K070745 — MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK (April 13, 2007)
K060981 — PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS (May 9, 2006)
K051446 — FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS (July 14, 2005)