Ximedica, LLC - April 13, 2022
Issue Date
Apr 13, 2022
Region
Northeast
Category
Device
$117.00
Contact Name
David W. Dockhorn
Contact Title
Chief Executive Officer
Address 1
55 Dupont Dr.
City
Providence
State
RI
Zip/Postal Code
02907-3105
Country
United States
Inspection Range
Apr 06, 2022 - Apr 13, 2022
Pages
3
First Observation
The design was not validated under defined operating conditions and using initial production units, lots or batches or their equivalents.
Investigator(s): Maryam Tabatabaie