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FDA 510(k)

Charisma

K-Number: K160049 · 2016-11-15

ApplicantHeraeus Kulzer, LLC (Mitsui Chemicals Group)
Decision Date2016-11-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Charisma is a medical device manufactured by Heraeus Kulzer, LLC (Mitsui Chemicals Group). It received FDA 510(k) clearance on 2016-11-15 under approval number K160049. 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 Charisma?

Charisma is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Heraeus Kulzer, LLC (Mitsui Chemicals Group). The 510(k) number is K160049.

When was Charisma approved by the FDA?

Charisma received FDA 510(k) clearance on 2016-11-15, under approval number K160049.

What company makes Charisma?

Charisma is manufactured by Heraeus Kulzer, LLC (Mitsui Chemicals Group).

What is the FDA product code for Charisma?

The FDA product code for Charisma is EBF.

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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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