Neurolumen, LLC - May 8, 2015
Issue Date
May 08, 2015
Region
Southwest
Category
Device
$117.00
Contact Name
Michelle L. Kudron
Contact Title
Office Manager
Address 1
9636 N. May Ave.
Address 2
Ste. 230
City
Oklahoma City,
State
OK
Zip/Postal Code
73120-2727
Country
United States
Inspection Range
May 04, 2015 - May 08, 2015
Pages
6
First Observation
The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.
Investigator(s): Leighton K. Ngai