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FDA 510(k)

PALACOS fast R+G

K-Number: K190766 · 2019-05-31

ApplicantHeraeus Medical GmbH
Decision Date2019-05-31
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PALACOS fast R+G is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical GmbH. It received FDA 510(k) clearance on 2019-05-31 under 510(k) 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. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K190766.

When did PALACOS fast R+G receive FDA 510(k) clearance?

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

Who is the listed applicant for PALACOS fast R+G?

The FDA 510(k) record lists Heraeus Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Heraeus Medical GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LOD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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