COTTONS 100% NATURAL COTTON TAMPONS


Device Classification Name

tampon, menstrual, unscented

510(k) Number K080733
Device Name COTTONS 100% NATURAL COTTON TAMPONS
Applicant
COTTONS PTY, LTD
3817 seville rd.
denton, 
TX 
76205 -8409

Applicant Contact robert seiple
Correspondent
COTTONS PTY, LTD
3817 seville rd.
denton, 
TX 
76205 -8409

Correspodent Contact robert seiple
Regulation Number 884.5470
Classification Product Code
HEB  
Date Received 03/14/2008
Decision Date 02/18/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No