FDA 510(k) Application Details - K053444

Device Classification Name	Tonometer, Ac-Powered   More FDA Info for this Device
510(K) Number	K053444
Device Name	Tonometer, Ac-Powered
Applicant	KOWA CO. LTD. 319 AKENO OBATA-CHO, WATARAI-GUN MIE-KEN 519-05 JP Other 510(k) Applications for this Company
Contact	SHINICHI YAMANAKA Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	HKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2005
Decision Date	06/09/2006
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