K-number	K220674
Device name	TargetCool
Applicant	Recensmedical, Inc.
Product code	GEH
Device class	Class II
Decision date	Mar 31, 2022
Decision	Substantially Equivalent
Regulation	878.4350

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Source

View the full FDA submission: accessdata.fda.gov

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TargetCool

Everything you need for a 510(k) submission. Nothing you don't.