Cleared Traditional

COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS

K152284 · Cotton High Tech S.L. · Obstetrics & Gynecology

Dec 2015

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K152284 is an FDA 510(k) clearance for the COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON 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 December 4, 2015, 114 days after receiving the submission on August 12, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K152284 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2015
Decision Date	December 04, 2015
Days to Decision	114 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.