FDA 510(k) Application Details - K153066

Device Classification Name	Lens, Contact (Other Material) - Daily   More FDA Info for this Device
510(K) Number	K153066
Device Name	Lens, Contact (Other Material) - Daily
Applicant	Boston Foundation for Sight 464 Hillside Avenue, Suite 205 Needham, MA 02494 US Other 510(k) Applications for this Company
Contact	Eugene Bonte Other 510(k) Applications for this Contact
Regulation Number	886.5916   More FDA Info for this Regulation Number
Classification Product Code	HQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2015
Decision Date	02/09/2016
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