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510(k) K891473

TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO by Tambrands, Inc. — Product Code HHL

K891473 is an FDA 510(k) premarket notification submitted by Tambrands, Inc. for the device "TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO". The FDA issued a decision of Substantially Equivalent on June 7, 1989. The device falls under product code HHL (Pad, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5425. Tambrands, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1989
Date Received
March 16, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Menstrual, Scented, Scented-Deodorized
Device Class
Class II
Regulation Number
884.5425
Review Panel
OB
Submission Type

Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).

Other clearances by Tambrands, Inc.

  • K962476 — UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR (August 13, 1996)
  • 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)
  • K923932 — TAMPAX TAMPONS, SUPER ABSORBENCY (July 29, 1993)
  • K924303 — TAMPAX TAMPON, REGULAR ABSORBENCY (July 29, 1993)
  • K896989 — TAMPAX TAMPON (December 22, 1989)
  • K896113 — TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS (December 13, 1989)
  • K896115 — TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER (December 13, 1989)
  • K896112 — TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS (December 13, 1989)

Other clearances for product code HHL

  • K962962 — DEODORANT PANTY LINER (October 10, 1996)
  • K962954 — DEODORANT MAXI PAD (October 10, 1996)
  • K962953 — DEODORANT PANTY SHIELD (October 10, 1996)
  • K961119 — CAREFREE PANTYLINERS (April 17, 1996)
  • K913237 — ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD (September 23, 1991)
  • K913238 — ALWAYS, UNSCENTED MENSTRUAL PAD (September 23, 1991)
  • K890655 — NEW FREEDOM THIN DEODORANT MAXI PADS (May 1, 1989)
  • K884951 — TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT (January 10, 1989)
  • K884446 — MAXITHINS SUPER PADS, DEODORANT (December 20, 1988)
  • K884444 — MAXITHINS REGULAR PADS, DEODORANT (December 5, 1988)

FDA data resources