Cleared Traditional

TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO

K891473 · Tambrands, Inc. · Obstetrics & Gynecology

Jun 1989

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K891473 is an FDA 510(k) clearance for the TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO, a Pad, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HHL), submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on June 7, 1989, 83 days after receiving the submission on March 16, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5425.

Submission Details

510(k) Number	K891473 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 1989
Decision Date	June 07, 1989
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—

Device Classification

Product Code	HHL — Pad, Menstrual, Scented, Scented-deodorized
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5425
Definition	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).