FDA 510(k), K153341, Relieva Scout Multi-Sinus Dilation System

FDA 510(k), K153341, Relieva Scout Multi-Sinus Dilation System

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510(K) Number: K153341
Device Name: Relieva Scout Multi-Sinus Dilation System
Manufacturer: ACCLARENT, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 11/19/2015
Decision Date: 02/12/2016
Regulation Medical Specialty: Ear Nose & Throat
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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