510(k) K132551

ZF 720 by Umbel Corporation — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2014
Date Received
August 14, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type