Shikani Medical, LLC dba The Airway Co. - Oct. 9, 2015
Issue Date
Oct 09, 2015
Region
Central
Category
Device
$117.00
Contact Name
Alan H. Shikani
Contact Title
President
Address 1
1629 York Rd.
Address 2
Ste. B
City
Lutherville
State
MD
Zip/Postal Code
21093-5633
Country
United States
Inspection Range
Oct 09, 2015 - Oct 09, 2015
Pages
2
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Marc S. Neubauer