FDA 510(k) Application Details - K093348

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K093348
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	GE HEALTHCARE COILS (USA INSTRUMENTS INC.) 3200 N GRANDVIEW BLVD., MAIL CODE : W-827 WAUKESHA, WI 53188-9273 US Other 510(k) Applications for this Company
Contact	ELIZABETH MATHEW 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	10/27/2009
Decision Date	11/25/2009
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