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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophageal Thermal Regulation And Gastric Suctioning Device
510(k) Number K170009
Device Name Esophageal Cooling Device
Applicant
Advanced Cooling Therapy, LLC
3440 S. Dearborn St.
#215-South
Chicago,  IL  60616
Applicant Contact Erik Kulstad
Correspondent
Advanced Cooling Therapy, LLC
3440 S. Dearborn St.
#215-South
Chicago,  IL  60616
Correspondent Contact Erik Kulstad
Regulation Number870.5910
Classification Product Code
PLA  
Date Received01/03/2017
Decision Date 03/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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