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510(k) K232060

TOSAMA Reusable Applicator by Tosama, D.O.O. — Product Code HEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2024
Date Received
July 11, 2023
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 Tosama, D.O.O.

  • K172504 — Tosama Biobased Applicator Tube Menstrual Tampon (February 9, 2018)
  • K151170 — Tosama 100% Organic Cotton Menstrual Tampon (July 2, 2015)
  • K150897 — Tosama 100% Cotton Menstrual Tampon (April 20, 2015)
  • K120481 — LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER P (July 13, 2012)
  • K092054 — MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON (July 29, 2009)
  • K080775 — MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS (September 10, 2008)

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)
  • K232598 — Unscented Menstrual Tampon (December 15, 2023)
  • K223883 — Daye Tampon (August 18, 2023)
  • K231341 — Organic cotton tampon, Viscose tampon (August 14, 2023)