Equashield LLC - Aug. 21, 2018
Issue Date
Aug 21, 2018
Region
Northeast
Category
Device
$117.00
Contact Name
Ron Melts
Contact Title
General Manager
Address 1
99 Seaview Blvd.
Address 2
Ste. 1D
City
Port Washington
State
NY
Zip/Postal Code
11050-4632
Country
United States
Inspection Range
Aug 07, 2018 - Aug 21, 2018
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): Andrew Garufi