Ultradent Products, Inc. - 11/8/2013
Issue Date
Nov 08, 2013
Region
Southwest
Category
Device
$117.00
Address 1
505 W. 10200 S
City
South Jordan
State
UT
Zip/Postal Code
84095-3935
Country
United States
Inspection Range
Nov 04, 2013 - Nov 08, 2013
Pages
6
First Observation
The design history file was not established and does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Janet Pulver