FDA 510(k), K162608, ClariFix Device

FDA 510(k), K162608, ClariFix Device

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510(K) Number: K162608
Device Name: ClariFix Device
Manufacturer: ARRINEX, INC.
Device Classification Name: unit, cryosurgical, accessories
Regulation Number: 878.4350
Classification Product Code: GEH
Date Received: 09/19/2016
Decision Date: 02/14/2017
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

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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