HEBU Medical GmbH - June 2, 2016
Issue Date
Jun 02, 2016
Region
HQ
Category
Device
$117.00
Contact Name
Thomas Butsch
Contact Title
CEO
Address 1
Badstrasse 8
City
Tuttlingen, Baden-Wurttemberg
Zip/Postal Code
78532
Country
Germany
Inspection Range
May 30, 2016 - Jun 02, 2016
Pages
2
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Brandi L. Garbutt