FDA 510(k) Application Details - K063155

Device Classification Name	Lens, Guide, Intraocular   More FDA Info for this Device
510(K) Number	K063155
Device Name	Lens, Guide, Intraocular
Applicant	ALCON MANUFACTURING, LTD. 6201 SOUTH FREEWAY FORT WORTH, TX 76134-2099 US Other 510(k) Applications for this Company
Contact	CATHERINE G GOBLE 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	10/17/2006
Decision Date	03/27/2007
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