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FDA 510(k), K152434, XprESS Multi-Sinus Dilation System
FDA 510(k), K152434, XprESS Multi-Sinus Dilation System
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510(K) Number: K152434
Device Name: XprESS Multi-Sinus Dilation System
Manufacturer: ENTELLUS MEDICAL, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 08/27/2015
Decision Date: 11/20/2015
Regulation Medical Specialty: Ear Nose & Throat
Device Name: XprESS Multi-Sinus Dilation System
Manufacturer: ENTELLUS MEDICAL, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 08/27/2015
Decision Date: 11/20/2015
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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