Medisurg Research & Management Corp - 3/16/2012
Issue Date
Mar 16, 2012
Region
Central
Category
Device
$117.00
Address 1
100 W Fornance Street
Address 2
The Fugo Building
City
Norristown
State
PA
Zip/Postal Code
19401
Country
United States
Inspection Range
Mar 09, 2012 - Mar 16, 2012
Pages
3
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Tania E. Vizcaino