FDA 510(k) Application Details - K000544

Device Classification Name	Reader, Prism, Ophthalmic   More FDA Info for this Device
510(K) Number	K000544
Device Name	Reader, Prism, Ophthalmic
Applicant	LABTICIAN OPHTHALMICS, INC. 2140 WINSTON PARK DR., UNIT 6 OAKVILLE, ONTARIO L6H 5V5 CA Other 510(k) Applications for this Company
Contact	R. DAVID SCULATI Other 510(k) Applications for this Contact
Regulation Number	886.5810   More FDA Info for this Regulation Number
Classification Product Code	HJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2000
Decision Date	03/09/2000
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