WAVi Co. - Jan. 29, 2018
Issue Date
Jan 29, 2018
Region
Southwest
Category
Device
$117.00
Contact Name
David S. Oakley
Contact Title
CEO
Address 1
3535 S. Irving St.
City
Englewood
State
CO
Zip/Postal Code
67530-6712
Country
United States
Inspection Range
Jan 24, 2018 - Jan 29, 2018
Pages
6
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Vicky L. Cruz