FDA 510(k) Application Details - K012698

Device Classification Name	Needle, Phacoemulsification, Reprocessed   More FDA Info for this Device
510(K) Number	K012698
Device Name	Needle, Phacoemulsification, Reprocessed
Applicant	VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. LAKELAND, FL 33815 US Other 510(k) Applications for this Company
Contact	MIKE SAMMON 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	08/14/2001
Decision Date	11/09/2001
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