FDA 510(k) Applications for Medical Device Product Code "HIL"
(Tampon, Menstrual, Scented, Deodorized)

FDA 510(k) Number Applicant Device Name Decision Date
K051446 FIRST QUALITY HYGIENIC INC. FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS 07/14/2005
K032173 FIRST QUALITY HYGIENIC, INC. FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS 09/03/2003
K050067 FIRST QUALITY HYGIENIC, INC. FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS 02/01/2005
K132208 ONTEX BVBA ONTEX AND OTHERS PROPRIETARY NAMES 04/10/2014
K132819 PLAYTEX MANUFACTURING INC. PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS 10/09/2013
K111684 PLAYTEX MANUFACTURING INC. PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD 02/03/2012
K022882 PLAYTEX PRODUCTS, INC. MODIFICATION TO PLAYTEX TAMPONS #24002 09/16/2002
K070745 PLAYTEX PRODUCTS, INC. MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS 04/13/2007
K982383 PLAYTEX PRODUCTS, INC. PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS 08/19/1998
K020202 PLAYTEX PRODUCTS, INC. PLAYTEX DEODORANT TAMPONS, MODEL 34702 03/12/2002
K020200 PLAYTEX PRODUCTS, INC. PLAYTEX DEODORANT TAMPONS, MODEL 34802 03/13/2002
K020201 PLAYTEX PRODUCTS, INC. PLAYTEX DEODORANT TAMPONS, MODEL 34902 03/12/2002
K073662 PLAYTEX PRODUCTS, INC. PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS 01/17/2008
K072376 PLAYTEX PRODUCTS, INC. PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS 12/12/2007
K961870 PLAYTEX PRODUCTS, INC. PLAYTEX SLIMFIT TAMPONS 06/19/1996
K060981 PLAYTEX PRODUCTS, INC. PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS 05/09/2006
K971547 PLAYTEX PRODUCTS, INC. PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS 06/19/1997
K120245 PLAYTEX, INC. PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS 06/21/2012
K961456 PLAYTIME PRODUCTS, INC. PLAYTEX TAMPONS #10296 06/18/1996
K964269 PLAYTIME PRODUCTS, INC. PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS 11/29/1996
K081555 PROCTER & GAMBLE CO. TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED 06/27/2008
K011996 PROCTER & GAMBLE CO. TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS 09/19/2001
K040312 PROCTER & GAMBLE CO. TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS 05/03/2004
K011171 PROCTER & GAMBLE CO. TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS 07/02/2001
K032080 ROSTAM LTD. ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS 08/14/2003
K042773 ROSTAM LTD. ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS 11/23/2004


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