Gyrus Acmi, Inc. - June 11, 2013
Issue Date
Jun 11, 2013
Region
Northeast
Category
Device
$117.00
Contact Name
Mark A. Jensen
Contact Title
VP of Regulatory Affairs & Quality
Address 1
136 Turnpike Rd.
City
Southborough
State
MA
Zip/Postal Code
01772-2118
Country
United States
Inspection Range
Jun 05, 2013 - Jun 11, 2013
Pages
2
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): Jonathan B. Lewis