Cleared Traditional

MAXITHINS SUPER PADS, DEODORANT

K884446 · Tambrands, Inc. · Obstetrics & Gynecology

Dec 1988

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K884446 is an FDA 510(k) clearance for the MAXITHINS SUPER PADS, DEODORANT, 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 December 20, 1988, 60 days after receiving the submission on October 21, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5425.

Submission Details

510(k) Number	K884446 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 1988
Decision Date	December 20, 1988
Days to Decision	60 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).