EndoChoice, Inc. - Sept. 8, 2014
Issue Date
Sep 08, 2014
Region
Southeast
Category
Device
$117.00
Contact Name
Nigel Wilkinson
Contact Title
Vice President of Quality Assurance and Regularity
Address 1
11810 Wills Rd.
Address 2
Ste 100
City
Alpharetta
State
GA
Zip/Postal Code
30009-2081
Country
United States
Inspection Range
Aug 20, 2014 - Sep 08, 2014
Pages
5
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Miaja Umaedi