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FDA 510(k), K140167, RENAISSANCE X SYSTEM
FDA 510(k), K140167, RENAISSANCE X SYSTEM
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510(K) Number: K140167
Device Name: RENAISSANCE X SYSTEM
Manufacturer: MAZOR ROBOTICS LTD
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 01/23/2014
Decision Date: 09/10/2014
Regulation Medical Specialty: Neurology
Device Name: RENAISSANCE X SYSTEM
Manufacturer: MAZOR ROBOTICS LTD
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 01/23/2014
Decision Date: 09/10/2014
Regulation Medical Specialty: Neurology
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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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