Cleared Special

COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT

K182813 · Cotton High Tech S.L. · Obstetrics & Gynecology

Mar 2019

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K182813 is an FDA 510(k) clearance for the COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Cotton High Tech S.L. (Balsareny, ES). The FDA issued a Cleared decision on March 15, 2019, 163 days after receiving the submission on October 3, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K182813 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 03, 2018
Decision Date	March 15, 2019
Days to Decision	163 days
Submission Type	Special
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.