King Systems Corp. dba Ambu, Inc. - Nov. 28, 2017
Issue Date
Nov 28, 2017
Region
Central
Category
Device
$117.00
Contact Name
Sanne Hentze
Contact Title
Vice President U.S. Operations
Address 1
15011 Herriman Blvd.
City
Noblesville
State
IN
Zip/Postal Code
46060-4253
Country
United States
Inspection Range
Nov 14, 2017 - Nov 28, 2017
Pages
5
First Observation
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.
Investigator(s): Debara R. Reese