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510(k) K962476

UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR by Tambrands, Inc. — Product Code HEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1996
Date Received
June 25, 1996
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 Tambrands, Inc.

  • K960341 — TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS (April 17, 1996)
  • K952344 — SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS (July 28, 1995)
  • K944834 — UNSCENTED MENSTRUAL TAMPONS (December 21, 1994)
  • K924303 — TAMPAX TAMPON, REGULAR ABSORBENCY (July 29, 1993)
  • K923932 — TAMPAX TAMPONS, SUPER ABSORBENCY (July 29, 1993)
  • K896989 — TAMPAX TAMPON (December 22, 1989)
  • K896115 — TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER (December 13, 1989)
  • K896113 — TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS (December 13, 1989)
  • K896112 — TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS (December 13, 1989)
  • K896114 — TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB. (December 13, 1989)

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)