Endo Optiks, Inc. - 1/11/2013
Issue Date
Jan 11, 2013
Region
Central
Category
Device
$117.00
Address 1
39 Sycamore Ave
City
Little Silver
State
NJ
Zip/Postal Code
07739
Country
United States
Inspection Range
Jan 08, 2013 - Jan 11, 2013
Pages
3
First Observation
The medical laser product does not incorporate in each Class III or IV medical laser product a means for the measurement of no more than 20% when calibrated in accordance with the CFR requirements.
Investigator(s): Amy M. Cramer and David H. Smith