FDA 510(k) Application Details - K050518

Device Classification Name	Needle, Phacoemulsification, Reprocessed   More FDA Info for this Device
510(K) Number	K050518
Device Name	Needle, Phacoemulsification, Reprocessed
Applicant	ALLIANCE MEDICAL, INC. 10232 SOUTH 51 ST. PHOENIX, AZ 85044 US Other 510(k) Applications for this Company
Contact	ELIZABETH RENKEN Other 510(k) Applications for this Contact
Regulation Number	886.4670   More FDA Info for this Regulation Number
Classification Product Code	NKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2005
Decision Date	09/23/2005
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