Cleared Traditional

MAXITHINS REGULAR PADS, DEODORANT

K884444 · Tambrands, Inc. · Obstetrics & Gynecology

Dec 1988

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K884444 is an FDA 510(k) clearance for the MAXITHINS REGULAR 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 5, 1988, 45 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	K884444 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 1988
Decision Date	December 05, 1988
Days to Decision	45 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).