FDA 510(k) Application Details - K102999

Device Classification Name	More FDA Info for this Device
510(K) Number	K102999
Device Name	TRIMOTION INJECTOR
Applicant	KANEKA CORP. 5-1-1, TORIKAI-NISHI SETTSU, OSAKA 566-0072 JP Other 510(k) Applications for this Company
Contact	TAMIJI FUJIMOTO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2010
Decision Date	12/29/2011
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