Surgentec, LLC - April 18, 2019
Issue Date
Apr 18, 2019
Region
Southeast
Category
Device
$117.00
Contact Name
Andrew J. Shoup
Contact Title
Chief Operating Officer
Address 1
7601 N Federal Hwy.
Address 2
Ste. 150a
City
Boca Raton
State
FL
Zip/Postal Code
33487- 1663
Country
United States
Inspection Range
Apr 15, 2019 - Apr 18, 2019
Pages
4
First Observation
Procedures for design validation have not been adequately established.
Investigator(s): Joshua J. Silvestri and David M. Wilkinson