FDA 510(k) Application Details - K112635

Device Classification Name	Tampon, Menstrual, Unscented   More FDA Info for this Device
510(K) Number	K112635
Device Name	Tampon, Menstrual, Unscented
Applicant	KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE ROAD ROSWELL, GA 30076 US Other 510(k) Applications for this Company
Contact	Swarna Mukund Other 510(k) Applications for this Contact
Regulation Number	884.5470   More FDA Info for this Regulation Number
Classification Product Code	HEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2011
Decision Date	10/07/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review