FDA 510(k) Application Details - K972506

Device Classification Name	Transilluminator, Ac-Powered   More FDA Info for this Device
510(K) Number	K972506
Device Name	Transilluminator, Ac-Powered
Applicant	INFINITECH, INC. 750 GODDARD AVE. CHESTERFIELD, MO 63005 US Other 510(k) Applications for this Company
Contact	ALAN T BECKMAN Other 510(k) Applications for this Contact
Regulation Number	886.1945   More FDA Info for this Regulation Number
Classification Product Code	HJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/1997
Decision Date	10/01/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review