Applied Medical Resources Corp. - Dec. 16, 2014
Issue Date
Dec 16, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Nabil Hilal
Contact Title
President
Address 1
22872 Avenida Empresa
City
Rancho Santa Margarita
State
CA
Zip/Postal Code
926882650
Country
United States
Inspection Range
Nov 03, 2014 - Dec 16, 2014
Pages
11
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a nmarketed 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): Kirtida Patel