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FDA 510(k), K181838, Sinusway Dilation System
FDA 510(k), K181838, Sinusway Dilation System
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$149.00 USD
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510(K) Number: K181838
Device Name: Sinusway Dilation System
Manufacturer: 3NT Medical Ltd.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 07/10/2018
Decision Date: 12/20/2018
Regulation Medical Specialty: Ear Nose & Throat
Device Name: Sinusway Dilation System
Manufacturer: 3NT Medical Ltd.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 07/10/2018
Decision Date: 12/20/2018
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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