LENSAR, Inc. - March 21, 2013
Issue Date
Mar 21, 2013
Region
Southeast
Category
Device
$117.00
Address 1
2800 Discovery Dr.
Address 2
Suite 100
City
Orlando
State
FL
Zip/Postal Code
32826-3010
Country
US
Inspection Range
Mar 18, 2013 - Mar 21, 2013
Pages
4
First Observation
A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups and reviews by a designated person was not included in the record.