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510(k) K952344

SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS by Tambrands, Inc. — Product Code HIL

K952344 is an FDA 510(k) premarket notification submitted by Tambrands, Inc. for the device "SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS". The FDA issued a decision of Substantially Equivalent on July 28, 1995. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Tambrands, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1995
Date Received
May 19, 1995
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 Tambrands, Inc.

  • K962476 — UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR (August 13, 1996)
  • K960341 — TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS (April 17, 1996)
  • K944834 — UNSCENTED MENSTRUAL TAMPONS (December 21, 1994)
  • K924303 — TAMPAX TAMPON, REGULAR ABSORBENCY (July 29, 1993)
  • K923932 — TAMPAX TAMPONS, SUPER ABSORBENCY (July 29, 1993)
  • K896989 — TAMPAX TAMPON (December 22, 1989)
  • K896113 — TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS (December 13, 1989)
  • K896112 — TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS (December 13, 1989)
  • K896115 — TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER (December 13, 1989)
  • K896114 — TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB. (December 13, 1989)

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)

FDA data resources