FDA 510(k) Application Details - K991302

Device Classification Name	Illuminator, Radiographic-Film   More FDA Info for this Device
510(K) Number	K991302
Device Name	Illuminator, Radiographic-Film
Applicant	SMARTLIGHT, INC. 241 MAIN ST. HACKENSACK, NJ 07601 US Other 510(k) Applications for this Company
Contact	A. ROBERT SOHOVAL Other 510(k) Applications for this Contact
Regulation Number	892.1890   More FDA Info for this Regulation Number
Classification Product Code	IXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/1999
Decision Date	06/01/1999
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