Circulatory Technology, Inc. - July 8, 2016
Issue Date
Jul 08, 2016
Region
Northeast
Category
Device
$117.00
Contact Name
Yehuda Tamari
Contact Title
President
Address 1
21 Singworth St.
City
Oyster Bay
State
NY
Zip/Postal Code
11771-3703
Country
United States
Inspection Range
Jun 06, 2016 - Jul 08, 2016
Pages
7
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): Ronald Ifraimov