Home / 510(k) Clearances / K970954

510(k) K970954

O.B. APPLICATOR TAMPONS by Personal Products Co. — Product Code HEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1997
Date Received
March 17, 1997
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)
  • K961119 — CAREFREE PANTYLINERS (April 17, 1996)
  • K953638 — O.B. APPLICATOR TAMPONS (October 20, 1995)
  • K941863 — O.B. TAMPON (June 27, 1994)

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)