Innovative Surgical Solutions, LLC dba SENTIO, LLC - May 20, 2015
Issue Date
May 20, 2015
Region
Central
Category
Device
$117.00
Contact Name
Christopher D. Wybo
Contact Title
President
Address 1
50461 W. Pontiac Trail
City
Wixom
State
MI
Zip/Postal Code
48393-2028
Country
United States
Inspection Range
May 12, 2015 - May 20, 2015
Pages
2
First Observation
The design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
Investigator(s): Deanna L. Lampley