FDA 510(k) Application Details - K121171

Device Classification Name	More FDA Info for this Device
510(K) Number	K121171
Device Name	CUROS TIP
Applicant	IVERA MEDICAL, INC. 2731 LOKER AVENUE WEST CARLSBAD, CA 92010 US Other 510(k) Applications for this Company
Contact	DON CANAL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2012
Decision Date	11/26/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review