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510(k) K953638

O.B. APPLICATOR TAMPONS by Personal Products Co. — Product Code HIL

K953638 is an FDA 510(k) premarket notification submitted by Personal Products Co. for the device "O.B. APPLICATOR TAMPONS". The FDA issued a decision of Substantially Equivalent on October 20, 1995. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Personal Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1995
Date Received
August 4, 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 Personal Products Co.

  • K070545 — K-Y BRAND WARMING LIQUID (March 23, 2007)
  • K062796 — K-Y BRAND INTRIGUE (December 8, 2006)
  • K010365 — ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (April 30, 2001)
  • K990536 — O.B. TAMPON (August 31, 1999)
  • K991118 — O.B. APPLICATOR TAMPONS, O.B. TAMPONS (June 29, 1999)
  • K974629 — O.B. APPLICATOR AND NON-APPLICATOR TAMPONS (February 10, 1998)
  • K971589 — REACH ANTIBACTERIAL TOOTHBRUSH (July 24, 1997)
  • K970954 — O.B. APPLICATOR TAMPONS (June 10, 1997)
  • K961119 — CAREFREE PANTYLINERS (April 17, 1996)
  • K941863 — O.B. TAMPON (June 27, 1994)

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