The following data is part of a premarket notification filed by Advanced Cooling Therapy, Llc with the FDA for Esophageal Cooling Device.
| Device ID | K152450 |
| 510k Number | K152450 |
| 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 | 2015-08-28 |
| Decision Date | 2016-01-15 |
| Summary: | summary |