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COMPLETE CONTROL System Gen2 — Coapt, LLC (510(k) K191083)

COMPLETE CONTROL System Gen2 — Coapt, LLC (510(k) K191083) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: COMPLETE CONTROL System Gen2; Applicant: Coapt, LLC; Clearance track: 510(k).

Device nameCOMPLETE CONTROL System Gen2
ApplicantCoapt, LLC
Clearance track510(k)
Submission numberK191083
DecisionSubstantially Equivalent
Decision date2019-05-24
Date received2019-04-24
Product codeGXY
Device class2
Medical specialtyNeurology
Applicant locationIL, US
SourceopenFDA device

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