FDA 510(k) Application Details - K003386

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K003386
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	MIDWEST R.F. LLC. 535 NORTON DR. P.O. BOX 350 HARTLAND, WI 53029 US Other 510(k) Applications for this Company
Contact	RALPH S HASHOIAN 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	10/31/2000
Decision Date	12/28/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review