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FDA 510(k), K180141, SPIWay Endonasal Access Guide
FDA 510(k), K180141, SPIWay Endonasal Access Guide
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510(K) Number: K180141
Device Name: SPIWay Endonasal Access Guide
Manufacturer: SPIWay, LLC
Device Classification Name: Splint, Intranasal Septal
Regulation Number: 874.4780
Classification Product Code: LYA
Date Received: 01/18/2018
Decision Date: 02/16/2018
Regulation Medical Specialty: Ear Nose & Throat
Device Name: SPIWay Endonasal Access Guide
Manufacturer: SPIWay, LLC
Device Classification Name: Splint, Intranasal Septal
Regulation Number: 874.4780
Classification Product Code: LYA
Date Received: 01/18/2018
Decision Date: 02/16/2018
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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