FDA 510(k) Application Details - K151961

Device Classification Name	Lens, Contact, Polymethylmethacrylate, Diagnostic   More FDA Info for this Device
510(K) Number	K151961
Device Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
Applicant	Volk Optical Inc. 7893 Enterprise Drive Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Meghan M Leonard Other 510(k) Applications for this Contact
Regulation Number	886.1385   More FDA Info for this Regulation Number
Classification Product Code	HJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2015
Decision Date	08/18/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review