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510(k) K081555

TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED by Procter & Gamble Co. — Product Code HIL

K081555 is an FDA 510(k) premarket notification submitted by Procter & Gamble Co. for the device "TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED". The FDA issued a decision of Substantially Equivalent on Jun 27, 2008. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Procter & Gamble Co. has 32 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 27, 2008
Date Received
Jun 3, 2008
Clearance Type
Special
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
510(k)

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 Procter & Gamble Co.

  • K203567 — Oral-B Dry Mouth Oral Rinse (Apr 5, 2021)
  • K201277 — Oral-B Dry Mouth Oral Rinse (Sep 2, 2020)
  • K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit (Aug 27, 2020)
  • K151413 — Always/Tampax bladder supports (Dec 18, 2015)
  • K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER… (Sep 15, 2014)
  • K133244 — TAMPAX M PLASTIC TAMPONS, UNSCENTED (Jan 9, 2014)
  • K131543 — TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED (Jun 20, 2013)
  • K113699 — TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED (Jan 12, 2012)
  • K110669 — TAMPAX C PLASTIC TAMPONS, UNSCENTED (Jun 2, 2011)
  • K091281 — TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL… (Jun 1, 2010)

Other clearances for product code HIL

  • K132208 — ONTEX AND OTHERS PROPRIETARY NAMES (Apr 10, 2014)
  • K132819 — PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (Oct 9, 2013)
  • K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (Jun 21, 2012)
  • K111684 — PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD (Feb 3, 2012)
  • K073662 — PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS (Jan 17, 2008)
  • K072376 — PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS (Dec 12, 2007)
  • K070745 — MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK… (Apr 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 (Jul 14, 2005)
  • K050067 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (Feb 1, 2005)

FDA data resources

Source: FDA 510(k) database entry for K081555. Report a data issue: hello@regdatalab.com.