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FDA 510(k), K151285, VSP Cranial System
FDA 510(k), K151285, VSP Cranial System
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510(K) Number: K151285
Device Name: VSP Cranial System
Manufacturer: Kim Torluemke
Device Classification Name: Cranial Surgical Planning And Instrument Guides
Regulation Number: PPT
Classification Product Code: KXA
Date Received: 05/14/2015
Decision Date: 09/23/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: VSP Cranial System
Manufacturer: Kim Torluemke
Device Classification Name: Cranial Surgical Planning And Instrument Guides
Regulation Number: PPT
Classification Product Code: KXA
Date Received: 05/14/2015
Decision Date: 09/23/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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