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510(k) K042773

ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS by Rostam , Ltd. — Product Code HIL

K042773 is an FDA 510(k) premarket notification submitted by Rostam , Ltd. for the device "ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS". The FDA issued a decision of Substantially Equivalent on November 23, 2004. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Rostam , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2004
Date Received
October 5, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tampon, Menstrual, Scented, Scented-Deodorized
Device Class
Class II
Regulation Number
884.5460
Review Panel
OB
Submission Type

A scented or scented-deodorized 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)
  • K030474 — PH BUFFERING PLASTIC APPLICATOR TAMPON (May 28, 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 HIL

  • K132208 — ONTEX AND OTHERS PROPRIETARY NAMES (April 10, 2014)
  • K132819 — PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (October 9, 2013)
  • K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (June 21, 2012)
  • K111684 — PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD (February 3, 2012)
  • K081555 — TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED (June 27, 2008)
  • K073662 — PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS (January 17, 2008)
  • K072376 — PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS (December 12, 2007)
  • K070745 — MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK (April 13, 2007)
  • K060981 — PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS (May 9, 2006)
  • K051446 — FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS (July 14, 2005)

FDA data resources