Surgical Appliances Industries - 6/1/2011
Issue Date
Jun 01, 2011
Region
Central
Category
Device
$117.00
Address 1
3960 Rosslyn Dr
City
Cincinnati
State
OH
Zip/Postal Code
45209
Country
United States
Inspection Range
May 16, 2011 - Jun 01, 2011
Pages
8
First Observation
Your firm has introduced or delivered for introduction into interstate commerce devices that have been significantly changed in intended use without submitting a premarket notification to FDA, as required by 21 807.81(a)(3).
Investigator(s): Maribeth G. Grattan and Elizabeth P. Kinsella