FDA 510(k) Application Details - K112112

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K112112
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	SENTINEL MEDICAL, INC. 555 RICHMOND STREET WEST SUITE 800 TORONTO M5V 3B1 CA Other 510(k) Applications for this Company
Contact	JOAN MEDLEY 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	07/25/2011
Decision Date	08/25/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review