FDA 510(k) Application Details - K160328

Device Classification Name	More FDA Info for this Device
510(K) Number	K160328
Device Name	DIVA ZSP2105CMI with QUBYX PerfectLum bundle
Applicant	THE LINDEN GROUP CORP. 2B WING DR CEDAR KNOLLS, NJ 079271020 US Other 510(k) Applications for this Company
Contact	ROBERT COLAIZZO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2016
Decision Date	02/25/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review