AccessClosure, Inc. - Aug. 5, 2014
Issue Date
Aug 05, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Susan M. Aloyan
Contact Title
Vice President
Address 1
5452 Betsy Rose Dr.
City
Santa Clara
State
CA
Zip/Postal Code
95054
Country
United States
Inspection Range
Jul 16, 2014 - Aug 05, 2014
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): Mary R. Hole