SPIWAY ENDONASAL ACCESS GUIDE— 510(k) K132721

Substantially Equivalent

Spiway, LLC

FDA 510(k) clearance K132721 for SPIWAY ENDONASAL ACCESS GUIDE, Substantially Equivalent on 2014-01-29. Applicant: Spiway, LLC. Device class: 1.

Clearance details

Applicant: Spiway, LLC
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2013-08-30
Decision date: 2014-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Beach, 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.