FDA 510(k) Application Details - K123028

Device Classification Name	More FDA Info for this Device
510(K) Number	K123028
Device Name	VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
Applicant	CALDERA MEDICAL, INC. 5171 CLARETON DRIVE AGOURA HILLS, CA 91301 US Other 510(k) Applications for this Company
Contact	VICKI GAIL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2012
Decision Date	04/25/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review