Advanced Cooling Therapy, Inc. - Oct. 22, 2021
Issue Date
Oct 22, 2021
Region
Central
Category
Device
$117.00
Contact Name
Eric B. Kulstad
Contact Title
Co-Founder, Chief Medical Officer
Address 1
3440 S. Dearborn St.
Address 2
Ste. 215-S
City
Chicago
State
IL
Zip/Postal Code
60616-5148
Country
United States
Inspection Range
Oct 19, 2021 - Oct 22, 2021
Pages
5
First Observation
The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
Investigator(s): Shafiq S. Ahadi