Esophageal Cooling Device

Esophageal Thermal Regulation And Gastric Suctioning Device

ADVANCED COOLING THERAPY, LLC

The following data is part of a premarket notification filed by Advanced Cooling Therapy, Llc with the FDA for Esophageal Cooling Device.

Pre-market Notification Details

Device IDK170009
510k NumberK170009
Device Name:Esophageal Cooling Device
ClassificationEsophageal Thermal Regulation And Gastric Suctioning Device
Applicant ADVANCED COOLING THERAPY, LLC 3440 S. Dearborn St. #215-South Chicago,  IL  60616
ContactErik Kulstad
CorrespondentErik Kulstad
ADVANCED COOLING THERAPY, LLC 3440 S. Dearborn St. #215-South Chicago,  IL  60616
Product CodePLA  
CFR Regulation Number870.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-03
Decision Date2017-03-30
Summary:summary

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