Latera Absorbable Nasal Implant— 510(k) K161191

Substantially Equivalent

Spirox, Inc.

FDA 510(k) clearance K161191 for Latera Absorbable Nasal Implant, Substantially Equivalent on 2016-06-23. Applicant: Spirox, Inc.. Device class: 2.

Clearance details

Applicant: Spirox, Inc.
Product code: Code NHB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2016-04-27
Decision date: 2016-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Menlo Park, CA, 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.