Topcon Medical Laser Systems, Inc. - July 10, 2013
Issue Date
Jul 10, 2013
Region
Pacific
Category
Device
$117.00
Contact Name
Toshihiko (NMI) Koike
Contact Title
President & CEO
Address 1
3130 Coronado Dr.
City
Santa Clara
State
CA
Zip/Postal Code
95054-3205
Country
United States
Inspection Range
Jun 26, 2013 - Jul 10, 2013
Pages
5
First Observation
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.
Investigator(s): Mary R. Hole