FDA 510(k) Application Details - K031831

Device Classification Name	Refractometer, Ophthalmic   More FDA Info for this Device
510(K) Number	K031831
Device Name	Refractometer, Ophthalmic
Applicant	TOPCON MEDICAL SYSTEMS, INC. 37 WEST CENTURY RD. PARAMUS, NJ 07652 US Other 510(k) Applications for this Company
Contact	DONALD H WINFIELD Other 510(k) Applications for this Contact
Regulation Number	886.1760   More FDA Info for this Regulation Number
Classification Product Code	HKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2003
Decision Date	12/19/2003
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