FDA 510(k) Application Details - K070130

Device Classification Name	Implant, Eye Sphere   More FDA Info for this Device
510(K) Number	K070130
Device Name	Implant, Eye Sphere
Applicant	BECKER & ASSOCIATES CONSULTING INC 2001 PENNSYLVANIA AVENUE NW SUITE 950 WASHINGTON, DC 20006 US Other 510(k) Applications for this Company
Contact	CAMPBELL TUSKEY Other 510(k) Applications for this Contact
Regulation Number	886.3320   More FDA Info for this Regulation Number
Classification Product Code	HPZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2007
Decision Date	04/19/2007
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