Stelkast, Inc. - March 23, 2015
Issue Date
Mar 23, 2015
Region
Central
Category
Device
$117.00
Contact Name
John K. Reyher
Contact Title
Sr. Vice President & General Manager
Address 1
200 Hidden Valley Rd.
City
Mcmurray
State
PA
Zip/Postal Code
15317-2659
Country
United States
Inspection Range
Mar 12, 2015 - Mar 26, 2015
Pages
3
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 has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Katelyn A. Staub-Zamperini