FDA 510(k) Application Details - K031788

Device Classification Name	Device,Analysis,Anterior Segment   More FDA Info for this Device
510(K) Number	K031788
Device Name	Device,Analysis,Anterior Segment
Applicant	MASSIE RESEARCH LABORATORIES, INC. 5775 W. LOS POSITAS SUITE 200 PLEASANTON, CA 94588-4084 US Other 510(k) Applications for this Company
Contact	N.A. (BERT) MASSIE 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	06/10/2003
Decision Date	09/02/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review