FDA 510(k) Application Details - K012373

Device Classification Name	Cassette, Radiographic Film   More FDA Info for this Device
510(K) Number	K012373
Device Name	Cassette, Radiographic Film
Applicant	FERRANIA S.P.A. 57 VIALE DELLA LIBERTA FERRANIA, SAVONA 17014 IT Other 510(k) Applications for this Company
Contact	MANNELA PAOLO Other 510(k) Applications for this Contact
Regulation Number	892.1850   More FDA Info for this Regulation Number
Classification Product Code	IXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2001
Decision Date	08/09/2001
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