K-number	K223605
Device name	ControlSeal Electrode (ELSB)
Applicant	Coapt
Product code	GXY
Device class	Class II
Decision date	Dec 30, 2022
Decision	Substantially Equivalent
Regulation	882.1320

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Source

View the full FDA submission: accessdata.fda.gov

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ControlSeal Electrode (ELSB)

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