FDA 510(k)

BioHPP - breCAM.BioHPP

K-Number: K152113 · 2016-07-21

Decision Date2016-07-21

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BioHPP - breCAM.BioHPP is a medical device manufactured by Bredent GmbH & Co. KG. It received FDA 510(k) clearance on 2016-07-21 under approval number K152113. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioHPP - breCAM.BioHPP?

BioHPP - breCAM.BioHPP is a medical device that received FDA 510(k) clearance on 2016-07-21. It is manufactured by Bredent GmbH & Co. KG. The 510(k) number is K152113.

When was BioHPP - breCAM.BioHPP approved by the FDA?

BioHPP - breCAM.BioHPP received FDA 510(k) clearance on 2016-07-21, under approval number K152113.

What company makes BioHPP - breCAM.BioHPP?

BioHPP - breCAM.BioHPP is manufactured by Bredent GmbH & Co. KG.

What is the FDA product code for BioHPP - breCAM.BioHPP?

The FDA product code for BioHPP - breCAM.BioHPP is EBF.

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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.