FDA 510(k), K171947, SOLOASSIST II

FDA 510(k), K171947, SOLOASSIST II

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510(K) Number: K171947
Device Name: SOLOASSIST II
Manufacturer: Andreas Mohr
Device Classification Name: System, Surgical, Computer Controlled Instrument
Regulation Number: NAY
Classification Product Code: KXA
Date Received: 06/29/2017
Decision Date: 09/21/2018
Decision: Substantially Equivalent (SESE)
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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