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
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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