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FDA 510(k), K163566, Hubble I System
FDA 510(k), K163566, Hubble I System
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$149.00 USD
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$149.00 USD
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510(K) Number: K163566
Device Name: Hubble I System
Manufacturer: Eric Garofano
Device Classification Name: Thoracolumbosacral Pedicle Screw System
Regulation Number: NKB
Classification Product Code: 12/19/2016
Date Received: 02/09/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Hubble I System
Manufacturer: Eric Garofano
Device Classification Name: Thoracolumbosacral Pedicle Screw System
Regulation Number: NKB
Classification Product Code: 12/19/2016
Date Received: 02/09/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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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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