FDA 510(k) Application Details - K983918

Device Classification Name	Cassette, Radiographic Film   More FDA Info for this Device
510(K) Number	K983918
Device Name	Cassette, Radiographic Film
Applicant	MASTEK, INC. 1200 BINZ, SUITE 1200 HOUSTON, TX 77004 US Other 510(k) Applications for this Company
Contact	MARCOS V MASSON 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	11/04/1998
Decision Date	03/12/1999
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