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FDA 510(k)

PALACOS fast R+G

K-Number: K190766 · 2019-05-31

Decision Date2019-05-31
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PALACOS fast R+G is a medical device manufactured by Heraeus Medical GmbH. It received FDA 510(k) clearance on 2019-05-31 under approval number K190766. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALACOS fast R+G?

PALACOS fast R+G is a medical device that received FDA 510(k) clearance on 2019-05-31. It is manufactured by Heraeus Medical GmbH. The 510(k) number is K190766.

When was PALACOS fast R+G approved by the FDA?

PALACOS fast R+G received FDA 510(k) clearance on 2019-05-31, under approval number K190766.

What company makes PALACOS fast R+G?

PALACOS fast R+G is manufactured by Heraeus Medical GmbH.

What is the FDA product code for PALACOS fast R+G?

The FDA product code for PALACOS fast R+G is LOD.

Other Devices by Heraeus Medical GmbH

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Related Devices (Code: LOD)

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.