FDA 510(k) Application Details - K033146

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K033146
Device Name	Tonometer, Manual
Applicant	TRA & ACCESSORIES 449 WEST ALLEN AVE. SUITE 107 SANDIMAS, CA 91773 US Other 510(k) Applications for this Company
Contact	RICHARD MASTROLEO 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	09/30/2003
Decision Date	11/23/2004
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