INT Contour— 510(k) K212274

Substantially Equivalent

Carina Medical, LLC

FDA 510(k) clearance K212274 for INT Contour, Substantially Equivalent on 2022-04-08. Applicant: Carina Medical, LLC. Device class: 2.

Clearance details

Applicant: Carina Medical, LLC
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2021-07-20
Decision date: 2022-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, KY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.