FDA 510(k) Application Details - K972655

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K972655
Device Name	System, X-Ray, Angiographic
Applicant	MEDICAL SPECIALTIES INTL., INC. 615 JASMINE AVENUE N. TARPON SPRINGS, FL 34689 US Other 510(k) Applications for this Company
Contact	LARRY G JUNKER Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/1997
Decision Date	11/04/1997
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