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FDA 510(k)

SurgiCase Viewer

K-Number: K170419 · 2017-05-11

Decision Date2017-05-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SurgiCase Viewer is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2017-05-11 under approval number K170419. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiCase Viewer?

SurgiCase Viewer is a medical device that received FDA 510(k) clearance on 2017-05-11. It is manufactured by Materialise NV. The 510(k) number is K170419.

When was SurgiCase Viewer approved by the FDA?

SurgiCase Viewer received FDA 510(k) clearance on 2017-05-11, under approval number K170419.

What company makes SurgiCase Viewer?

SurgiCase Viewer is manufactured by Materialise NV.

What is the FDA product code for SurgiCase Viewer?

The FDA product code for SurgiCase Viewer is LLZ.

Other Devices by Materialise NV

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Related Devices (Code: LLZ)

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.