FDA 510(k) Application Details - K000288

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K000288
Device Name	Tonometer, Manual
Applicant	REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC. 3374 WALDEN AVE. DEPEW, NY 14043 US Other 510(k) Applications for this Company
Contact	FRANK J DREXELIUS Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	HKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2000
Decision Date	03/23/2000
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