510(k) K030474

PH BUFFERING PLASTIC APPLICATOR TAMPON by Rostam , Ltd. — Product Code HEB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 28, 2004
Date Received: February 12, 2003
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 Rostam , Ltd.

K102445 — ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS (November 10, 2010)
K090071 — ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS (May 28, 2009)
K062001 — ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS (December 7, 2006)
K042773 — ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS (November 23, 2004)
K032080 — ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS (August 14, 2003)
K020535 — INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS (May 9, 2002)
K001641 — TAMPONS (August 3, 2000)
K965064 — ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON (February 20, 1997)

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)