Medical Instrument Development Laboratories, Inc. - Aug. 14, 2015
Issue Date
Aug 14, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Brenda M. Balletto
Contact Title
Vice President of Quality and Regulatory
Address 1
557 McCormick St.
City
San Leandro
State
CA
Zip/Postal Code
94577-1107
Country
United States
Inspection Range
Aug 04, 2015 - Aug 14, 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): Adam S. Freeman