Porex Surgical, Inc. - September 30, 2009
Issue Date
Sep 30, 2009
Region
Southeast
Category
Device
$117.00
Address 1
15 Dart Rd.
City
Newnan
State
GA
Zip/Postal Code
30265-1017
Country
US
Inspection Range
Sep 25, 2009 - Sep 30, 2009
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 market device may have caused or contributed to a death or serious injury.
Investigator(s): Myoshi M. Francis and Miaja Umaedi