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FDA 510(k), K161090, Cranial PSI
FDA 510(k), K161090, Cranial PSI
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510(K) Number: K161090
Device Name: Cranial PSI
Manufacturer: ULRIK BIRGERSSON
Device Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable
Regulation Number: GXN
Classification Product Code: 04/18/2016
Date Received: 01/19/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Cranial PSI
Manufacturer: ULRIK BIRGERSSON
Device Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable
Regulation Number: GXN
Classification Product Code: 04/18/2016
Date Received: 01/19/2017
Decision Date: Substantially Equivalent (SESE)
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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