ControlSeal Electrode (ELSB)— 510(k) K223605

Substantially Equivalent

Coapt

FDA 510(k) clearance K223605 for ControlSeal Electrode (ELSB), Substantially Equivalent on 2022-12-30. Applicant: Coapt.

Clearance details

Applicant: Coapt
Product code: Code GXY
Advisory panel: Neurology
Date received: 2022-12-02
Decision date: 2022-12-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Chicago, IL, US

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