FDA 510(k) Application Details - K110411

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K110411
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	MONTERIS MEDICAL, INC. 100 - 78 Innovation Drive Winnipeg R3T 6C2 CA Other 510(k) Applications for this Company
Contact	JEFF WILSON Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	MOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2011
Decision Date	04/08/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review