FDA 510(k) Application Details - K042742

Device Classification Name	Device,Analysis,Anterior Segment   More FDA Info for this Device
510(K) Number	K042742
Device Name	Device,Analysis,Anterior Segment
Applicant	HEIDELBERG ENGINEERING GERHART-HAUPTMANN-STRASSE 30 DOSSENHEIM 69221 DE Other 510(k) Applications for this Company
Contact	GERHARD ZINSER Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	MXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2004
Decision Date	10/13/2004
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	Y
Expedited Review