FDA 510(k) Application Details - K143351

Device Classification Name	Case, Contact Lens   More FDA Info for this Device
510(K) Number	K143351
Device Name	Case, Contact Lens
Applicant	Novabay Pharmaceuticals, Inc 5980 Horton St., Suite 550 Emeryville, CA 94608 US Other 510(k) Applications for this Company
Contact	Charles Francavilla Other 510(k) Applications for this Contact
Regulation Number	886.5928   More FDA Info for this Regulation Number
Classification Product Code	LRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2014
Decision Date	04/29/2015
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