Peak Surgical - Aug. 18, 2010
Issue Date
Aug 18, 2010
Region
Pacific
Category
Device
$117.00
Address 1
2464 Embarcadero Way
City
Palo Alto
State
CA
Zip/Postal Code
94303-3313
Country
US
Inspection Range
Aug 09, 2010 - Aug 18, 2010
Pages
3
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): Christine M. Parmentier