Ondamed, Inc. - Aug. 17, 2015
Issue Date
Aug 17, 2015
Region
Northeast
Category
Device
$117.00
Contact Name
William K. Tranum
Contact Title
Manufacturing & Technical Customer Support Manager
Address 1
2570 U.S. Highway 9w
City
Cornwall
State
NY
Zip/Postal Code
12518-1323
Country
United States
Inspection Range
Jul 28, 2015 - Aug 17, 2015
Pages
5
First Observation
The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
Investigator(s): Scott R. Izyk and Jacqueline S. Warner