Patient-Specific Airway Stent— 510(k) K182743

Substantially Equivalent

New Cos, Inc.

FDA 510(k) clearance K182743 for Patient-Specific Airway Stent, Substantially Equivalent on 2019-10-23. Applicant: New Cos, Inc.. Device class: 2.

Clearance details

Applicant: New Cos, Inc.
Product code: Code NWA
Device class: Class 2
Regulation: 21 CFR 878.3720
Advisory panel: General, Plastic Surgery
Date received: 2018-09-28
Decision date: 2019-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.