510(k) K894846

UNSCENTED MENSTRUAL TAMPON by Personal Products Co. — Product Code HEB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 16, 1989
Date Received: July 31, 1989
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 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)
K953638 — O.B. APPLICATOR TAMPONS (October 20, 1995)

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)