FDA 510(k) Application Details - K080820

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K080820
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	MR INSTRUMENTS, INC. 5610 ROWLAND ROAD SUITE 145 MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	MARK WATSON 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	03/24/2008
Decision Date	04/02/2008
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