Alpha Control Liner System (ACLS)— 510(k) K223738

Substantially Equivalent

Coapt

FDA 510(k) clearance K223738 for Alpha Control Liner System (ACLS), Substantially Equivalent on 2023-01-11. Applicant: Coapt.

Clearance details

Applicant: Coapt
Product code: Code GXY
Advisory panel: Neurology
Date received: 2022-12-14
Decision date: 2023-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Chicago, IL, US

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