FDA 510(k) Application Details - K070669

Device Classification Name	Lens, Guide, Intraocular   More FDA Info for this Device
510(K) Number	K070669
Device Name	Lens, Guide, Intraocular
Applicant	MEDICEL AG 377 ROUTE 17 S HASBROUCK HEIGHTS, NJ 07604 US Other 510(k) Applications for this Company
Contact	GEORGE MYERS Other 510(k) Applications for this Contact
Regulation Number	886.4300   More FDA Info for this Regulation Number
Classification Product Code	KYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2007
Decision Date	11/01/2007
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