K-number	DEN140018
Device name	ESOPHAGEAL COOLING DEVICE
Applicant	Advanced Cooling Therapy, LLC
Product code	PLA
Device class	Class II
Decision date	Jun 23, 2015
Decision	Not Substantially Equivalent
Regulation	870.5910

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View the full FDA submission: accessdata.fda.gov

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ESOPHAGEAL COOLING DEVICE

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