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FDA 510(k)

VSP Cranial System

K-Number: K151285 · 2016-09-23

Decision Date2016-09-23
Product CodePPT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VSP Cranial System is a medical device manufactured by 3D Systems, Inc.. It received FDA 510(k) clearance on 2016-09-23 under approval number K151285. The device is classified under product code PPT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VSP Cranial System?

VSP Cranial System is a medical device that received FDA 510(k) clearance on 2016-09-23. It is manufactured by 3D Systems, Inc.. The 510(k) number is K151285.

When was VSP Cranial System approved by the FDA?

VSP Cranial System received FDA 510(k) clearance on 2016-09-23, under approval number K151285.

What company makes VSP Cranial System?

VSP Cranial System is manufactured by 3D Systems, Inc..

What is the FDA product code for VSP Cranial System?

The FDA product code for VSP Cranial System is PPT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.