Cleared Traditional

MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS

K091084 · Cotton High Tech S.L. · Obstetrics & Gynecology

Apr 2009

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K091084 is an FDA 510(k) clearance for the MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Cotton High Tech S.L. (Barcelona, ES). The FDA issued a Cleared decision on April 29, 2009, 14 days after receiving the submission on April 15, 2009. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K091084 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 2009
Decision Date	April 29, 2009
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented 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.