FDA 510(k), K062458, ETHMOID SINUS SPACER
FDA 510(k), K062458, ETHMOID SINUS SPACER
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510(K) Number: K062458
Device Name: ETHMOID SINUS SPACER
Manufacturer: ACCLARENT, INC.
Device Classification Name: cannula, sinus
Regulation Number: 878.4800
Classification Product Code: KAM
Date Received: 08/23/2006
Decision Date: 09/15/2006
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ETHMOID SINUS SPACER
Manufacturer: ACCLARENT, INC.
Device Classification Name: cannula, sinus
Regulation Number: 878.4800
Classification Product Code: KAM
Date Received: 08/23/2006
Decision Date: 09/15/2006
Regulation Medical Specialty: General & Plastic Surgery
- 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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