FDA 510(k) Application Details - K013229

Device Classification Name	Cassette, Radiographic Film   More FDA Info for this Device
510(K) Number	K013229
Device Name	Cassette, Radiographic Film
Applicant	FERRANIA USA, INC. 2700 EAST FRONTAGE RD. WEATHERFORD, OK 73096-6104 US Other 510(k) Applications for this Company
Contact	DOUG HALE 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	09/27/2001
Decision Date	10/12/2001
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