510(k) K080775

MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS by Tosama D.D. — Product Code HEB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 10, 2008
Date Received: March 19, 2008
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

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.D.

K232060 — TOSAMA Reusable Applicator (April 12, 2024)
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)

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)