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510(k) K180167

Playtex Stella Tampons by Playtex Manufacturing, Inc. — Product Code HEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2018
Date Received
January 22, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tampon, Menstrual, Unscented
Device Class
Class II
Regulation Number
884.5470
Review Panel
OB
Submission Type

An unscented 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 Playtex Manufacturing, Inc.

  • K132819 — PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (October 9, 2013)
  • K111684 — PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD (February 3, 2012)

Other clearances for product code HEB

  • K253719 — Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applic (December 17, 2025)
  • K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (October 9, 2025)
  • K252613 — Unscented menstrual three-piece applicator tampon (September 19, 2025)
  • K251033 — Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicat (August 13, 2025)
  • K242105 — SABA Tampons (April 1, 2025)
  • K241064 — Unscented Tampon (January 10, 2025)
  • K240708 — Organic Cotton Tampon; Organic Cotton PESCVcord Tampon (May 10, 2024)
  • K232060 — TOSAMA Reusable Applicator (April 12, 2024)
  • K232598 — Unscented Menstrual Tampon (December 15, 2023)
  • K223883 — Daye Tampon (August 18, 2023)