FDA 510(k) Application Details - K121913

Device Classification Name	More FDA Info for this Device
510(K) Number	K121913
Device Name	REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER
Applicant	STRYKER SUSTAINABILITY SOLUTIONS, INC. 10232 S. 51st St. Phoenix, AZ 85044 US Other 510(k) Applications for this Company
Contact	MOIRA BARTON-VARTY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2012
Decision Date	12/20/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review