FDA 510(k) Application Details - K100954

Device Classification Name	More FDA Info for this Device
510(K) Number	K100954
Device Name	ADAPT, MODEL AX-03SN
Applicant	APELIOTUS VISION SCIENCE, INC 1456 N. MORNINGSIDE DRIVE, NE ATLANTA, GA 30306 US Other 510(k) Applications for this Company
Contact	JOHN G EDWARDS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2010
Decision Date	02/25/2011
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