FDA 510(k) Application Details - K140843

Device Classification Name	More FDA Info for this Device
510(K) Number	K140843
Device Name	DESARA BLUE OV, DESARA BLUE SS
Applicant	CALDERA MEDICAL 5171 Clareton Dr 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	OTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/2014
Decision Date	07/01/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review