FDA 510(k) Application Details - K111339

Device Classification Name	Analyzer, Heparin, Automated   More FDA Info for this Device
510(K) Number	K111339
Device Name	Analyzer, Heparin, Automated
Applicant	MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	AMRA RACIC Other 510(k) Applications for this Contact
Regulation Number	864.5680   More FDA Info for this Regulation Number
Classification Product Code	JOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2011
Decision Date	06/08/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review