DUX Dental, Inc. - Sept. 29, 2014
Issue Date
Oct 27, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Frank C. Rovelli
Contact Title
Vice President & General Manager
Address 1
600 E. Hueneme Rd.
City
Oxnard
State
CA
Zip/Postal Code
93033-8634
Country
United States
Inspection Range
Sep 18, 2014 - Sep 29, 2014
Pages
8
First Observation
Procedures for design validation have not been adequately established.
Investigator(s): Donna L. Tartaglino Besone