Jonathan V. Wright - June 20, 2017
Issue Date
Jun 20, 2017
Region
Pacific
Category
Clinical
$117.00
Address 1
6839 Fort Dent Way
Address 2
Ste. 107
City
Tukwila
State
WA
Zip/Postal Code
98188
Country
United States
Inspection Range
May 09, 2017 - Jun 20, 2017
Pages
6
First Observation
A clinical investigation that was determined to be a non-significant risk device study does not meet the abbreviated requirements for investigational device exemptions (IDEs).
Investigator(s): Cynthia L. Gorveatt and Sunitha K. Rajaram