FDA 510(k) Application Details - K070534

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K070534
Device Name	Tonometer, Manual
Applicant	REICHERT, INC. 3362 WALDEN AVE. DEPEW, NY 14043 US Other 510(k) Applications for this Company
Contact	SANDRA BROWN 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	02/26/2007
Decision Date	03/27/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review