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FDA 510(k), K121936, NAVIOPFS
FDA 510(k), K121936, NAVIOPFS
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510(K) Number: K121936
Device Name: NAVIOPFS
Manufacturer: BLUE BELT TECHNOLOGIES, INC.
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 07/02/2012
Decision Date: 11/30/2012
Regulation Medical Specialty: Neurology
Device Name: NAVIOPFS
Manufacturer: BLUE BELT TECHNOLOGIES, INC.
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 07/02/2012
Decision Date: 11/30/2012
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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