510(k) K874509

PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL by Playtex, Inc. — Product Code HIL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 7, 1988
Date Received: November 2, 1987
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, Inc.

K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (June 21, 2012)
K980478 — PLAYTEX TAMPONS #03498 (April 3, 1998)
K971174 — PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS (May 21, 1997)
K944064 — PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894 (February 9, 1995)
K941044 — PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194 (July 27, 1994)
K942418 — PLAYTEX TAMPONS MODEL 13794 (July 8, 1994)
K881057 — PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER (March 22, 1988)
K843551 — PLAYTEX BABY POWDER DEODORANT TAMPONS (December 3, 1984)
K841154 — PLAYTEX SLENDER REGULAR TAMPONS (March 19, 1984)
K841155 — DEODORANT SLENDER REG. TAMPONS (March 19, 1984)

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)