NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER— 510(k) K140542

Name: FDA 510(k) clearance K140542
Creator: U.S. Food and Drug Administration
Published: 2014-06-27

Substantially Equivalent

Rhinosystems, Inc.

FDA 510(k) clearance K140542 for NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER, Substantially Equivalent on 2014-06-27. Applicant: Rhinosystems, Inc.. Device class: 1.

Clearance details

Applicant: Rhinosystems, Inc.
Product code: Code KMA
Device class: Class 1
Regulation: 21 CFR 874.5550
Advisory panel: Ear, Nose, Throat
Date received: 2014-03-04
Decision date: 2014-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn Heights, OH, US

Download summary PDF View on FDA.gov ↗

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