The following data is part of a premarket notification filed by Advanced Cooling Therapy, Llc with the FDA for Esophageal Cooling Device.
Device ID | K170009 |
510k Number | K170009 |
Device Name: | Esophageal Cooling Device |
Classification | Esophageal Thermal Regulation And Gastric Suctioning Device |
Applicant | ADVANCED COOLING THERAPY, LLC 3440 S. Dearborn St. #215-South Chicago, IL 60616 |
Contact | Erik Kulstad |
Correspondent | Erik Kulstad ADVANCED COOLING THERAPY, LLC 3440 S. Dearborn St. #215-South Chicago, IL 60616 |
Product Code | PLA |
CFR Regulation Number | 870.5910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-03 |
Decision Date | 2017-03-30 |
Summary: | summary |