U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS


Device Classification Name

tampon, menstrual, unscented

510(k) Number K112635
Device Name U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
Applicant
KIMBERLY-CLARK CORP.
1400 holcomb bridge road
roswell, 
GA 
30076

Applicant Contact swarna mukund
Correspondent
KIMBERLY-CLARK CORP.
1400 holcomb bridge road
roswell, 
GA 
30076

Correspodent Contact swarna mukund
Regulation Number 884.5470
Classification Product Code
HEB  
Date Received 09/09/2011
Decision Date 10/07/2011
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