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FDA 510(k), K093594, MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
FDA 510(k), K093594, MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
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510(K) Number: K093594
Device Name: MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
Manufacturer: ACCLARENT, INC.
Device Classification Name: cannula, sinus
Regulation Number: 878.4800
Classification Product Code: KAM
Date Received: 11/19/2009
Decision Date: 03/03/2010
Regulation Medical Specialty: General & Plastic Surgery
Device Name: MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
Manufacturer: ACCLARENT, INC.
Device Classification Name: cannula, sinus
Regulation Number: 878.4800
Classification Product Code: KAM
Date Received: 11/19/2009
Decision Date: 03/03/2010
Regulation Medical Specialty: General & Plastic Surgery
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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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