FDA 510(k) Application Details - K091039

Device Classification Name	Ophthalmoscope,Laser,Scanning   More FDA Info for this Device
510(K) Number	K091039
Device Name	Ophthalmoscope,Laser,Scanning
Applicant	KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO 3-CHOME CHUO-KU, TOKYO 103-8433 JP Other 510(k) Applications for this Company
Contact	SATOHIKO TAKANASHI Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	MYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2009
Decision Date	08/07/2009
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