Electro-Cap International, Inc. - April 28, 2011
Issue Date
Apr 28, 2011
Region
Central
Category
Device
$117.00
Address 1
1011 W. Lexington Rd.
City
Eaton
State
OH
Zip/Postal Code
45320
Country
US
Inspection Range
Apr 18, 2011 - Apr 28, 2011
Pages
3
First Observation
Your firm has introduced or delivered for introduction into interstate commerce a device that has been significantly changed or modified in materials and chemical composition without submitting a premarket notification to FDA, as required by 21 CFR 807.81(a)(3).
Investigator(s): Brigitte K. Hofmann