Pentax of America, Inc. - Sept. 27, 2018
Issue Date
Sep 27, 2018
Region
Central
Category
Device
$117.00
Contact Name
David G. Woods
Contact Title
President
Address 1
3 Paragon Dr.
City
Montvale
State
NJ
Zip/Postal Code
07645-1782
Country
United States
Inspection Range
Aug 15, 2018 - Sep 27, 2018
Pages
6
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): David H. Smith