U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS


Device Classification Name

tampon, menstrual, unscented

510(k) Number K113036
Device Name U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS
Applicant
KIMBERLY-CLARK CORPORATION
2001 marathon ave
neeah, 
WI 
54956

Applicant Contact lori barr
Correspondent
KIMBERLY-CLARK CORPORATION
2001 marathon ave
neeah, 
WI 
54956

Correspodent Contact lori barr
Regulation Number 884.5470
Classification Product Code
HEB  
Date Received 10/12/2011
Decision Date 11/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No