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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 K180244
Device Name EnsoETM
Applicant
Advanced Cooling Therapy, Inc. D/B/A Attune Medical
3440 S. Dearborn St.
#215-South
Chicago,  IL  60616
Applicant Contact Erik Kulstad
Correspondent
Advanced Cooling Therapy, Inc. D/B/A Attune Medical
3440 S. Dearborn St.
#215-South
Chicago,  IL  60616
Correspondent Contact Erik Kulstad
Regulation Number870.5910
Classification Product Code
PLA  
Date Received01/29/2018
Decision Date 02/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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