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FDA 510(k), K123633, TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
FDA 510(k), K123633, TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
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510(K) Number: K123633
Device Name: TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
Manufacturer: TISSUE REGENERATION SYSTEMS, INC.
Device Classification Name: cover, burr hole
Regulation Number: 882.5250
Classification Product Code: GXR
Date Received: 11/23/2012
Decision Date: 08/16/2013
Regulation Medical Specialty: Neurology
Device Name: TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
Manufacturer: TISSUE REGENERATION SYSTEMS, INC.
Device Classification Name: cover, burr hole
Regulation Number: 882.5250
Classification Product Code: GXR
Date Received: 11/23/2012
Decision Date: 08/16/2013
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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