FDA 510(k) Application Details - K151575

Device Classification Name	Cup, Eye   More FDA Info for this Device
510(K) Number	K151575
Device Name	Cup, Eye
Applicant	DYNAREX CORPORATION 10 GLENSHAW STREET ORANGEBURG, NY 10962 US Other 510(k) Applications for this Company
Contact	JAMES HURLMAN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2015
Decision Date	09/01/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review