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FDA 510(k)

DB-CMF

K-Number: K182742 · 2019-06-20

Decision Date2019-06-20
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DB-CMF is a medical device manufactured by Dimensional Bioceramics, LLC. It received FDA 510(k) clearance on 2019-06-20 under approval number K182742. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DB-CMF?

DB-CMF is a medical device that received FDA 510(k) clearance on 2019-06-20. It is manufactured by Dimensional Bioceramics, LLC. The 510(k) number is K182742.

When was DB-CMF approved by the FDA?

DB-CMF received FDA 510(k) clearance on 2019-06-20, under approval number K182742.

What company makes DB-CMF?

DB-CMF is manufactured by Dimensional Bioceramics, LLC.

What is the FDA product code for DB-CMF?

The FDA product code for DB-CMF is GXP.

Other Devices by Dimensional Bioceramics, LLC

Related Devices (Code: GXP)

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.