Aggredyne, Inc. - April 14, 2022
Issue Date
Apr 14, 2022
Region
Southwest
Category
Device
$117.00
Contact Name
Robert C. Hux
Contact Title
President/CEO
Address 1
10530 Rockley Rd.
Address 2
Ste. 150
City
Houston
State
TX
Zip/Postal Code
77099-3574
Country
United States
Inspection Range
Mar 29, 2022 - Apr 14, 2022
Pages
13
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Jocelyn C. Turner