FDA 510(k) Application Details - K053475

Device Classification Name	Marker, Ocular   More FDA Info for this Device
510(K) Number	K053475
Device Name	Marker, Ocular
Applicant	REFRACTEC, INC. 5 JENNER, SUITE 150 IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	GARY MOCNIK Other 510(k) Applications for this Contact
Regulation Number	886.4570   More FDA Info for this Regulation Number
Classification Product Code	HMR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2005
Decision Date	03/03/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review