Cardiva Medical, Inc. - September 3, 2009
Issue Date
Sep 03, 2009
Region
Pacific
Category
Device
$117.00
Address 1
888 W. Maude Ave.
City
Sunnyvale
State
CA
Zip/Postal Code
94085
Country
US
Inspection Range
Aug 25, 2009 - Sep 03, 2009
Pages
2
First Observation
The design history files does not demonstrate that the design was developed following the approved design plan and the design control requirements of 21 CFR 820.
Investigator(s): Gary L. Zaharek