MicroAire Surgical Instruments, LLC - August 22, 2014
Issue Date
Aug 22, 2014
Region
Central
Category
Device
$117.00
Contact Name
Michael C. Williams
Contact Title
Vice President
Address 1
3590 Grand Forks Blvd.
City
Charlottesville
State
VA
Zip/Postal Code
22911-9001
Country
United States
Inspection Range
Aug 11, 2014 - Aug 22, 2014
Pages
10
First Observation
Software used as part of production and the quality system has not been validated for its intended use according to an established protocol.
Investigator(s): Marc S. Neubauer and Joey C. West