510(k) K132208

ONTEX AND OTHERS PROPRIETARY NAMES by Ontex Bvba — Product Code HIL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 10, 2014
Date Received: July 16, 2013
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 Ontex Bvba

K191666 — Unscented W long plastic and cardboard applicator tampons (December 20, 2019)
K162746 — Ontex and other proprietary names (March 3, 2017)
K142786 — Ontex Unscented Tampons with Colored Plastic Applicators (June 23, 2015)
K132595 — ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS (April 23, 2014)
K122603 — ONTEX AND OTHER PROPRIETARY NAMES (December 19, 2012)

Other clearances for product code HIL

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)
K050067 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (February 1, 2005)