FDA 510(k) Application Details - K103274

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K103274
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	SENTINELLE MEDICAL, INC. 555 RICHMOND STREET W SUITE 800, PO BOX 301 TORONTO, ONTARIO M5V 3B1 CA Other 510(k) Applications for this Company
Contact	CAMERON PIRON 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	11/05/2010
Decision Date	08/18/2011
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	Y
Expedited Review