Novapak Nasal Sinus Packing and Stent— 510(k) K202623

Name: FDA 510(k) clearance K202623
Creator: U.S. Food and Drug Administration
Published: 2020-12-08

Substantially Equivalent

Medtronic Xomed

FDA 510(k) clearance K202623 for Novapak Nasal Sinus Packing and Stent, Substantially Equivalent on 2020-12-08. Applicant: Medtronic Xomed. Device class: 1.

Clearance details

Applicant: Medtronic Xomed
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2020-09-10
Decision date: 2020-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, 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.