Nidek, Inc. - June 10, 2015
Issue Date
Jun 10, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Jun Iwata
Contact Title
Chief Operating Officer
Address 1
47651 Westinghouse Dr.
City
Fremont
State
CA
Zip/Postal Code
94539-7474
Country
United States
Inspection Range
May 19, 2015 - Jun 10, 2015
Pages
2
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): Maida Henesian