FDA 510(k) Application Details - K120327

Device Classification Name	More FDA Info for this Device
510(K) Number	K120327
Device Name	VERTESSA
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	02/02/2012
Decision Date	05/10/2012
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