FDA 510(k) Application Details - K981280

Device Classification Name	Processor, Radiographic-Film, Automatic   More FDA Info for this Device
510(K) Number	K981280
Device Name	Processor, Radiographic-Film, Automatic
Applicant	BAYER CORP., AGFA DIV. 100 CHALLENGER RD. RIDGEFIELD PARK, NJ 07660 US Other 510(k) Applications for this Company
Contact	MICHAEL SULLIVAN Other 510(k) Applications for this Contact
Regulation Number	892.1900   More FDA Info for this Regulation Number
Classification Product Code	IXW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/1998
Decision Date	04/30/1998
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	N
Expedited Review