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FDA 510(k)

CHARISMA SINGLE DOSE

K-Number: K954929 · 1995-11-27

ApplicantHeraeus Kulzer, Inc.
Decision Date1995-11-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHARISMA SINGLE DOSE is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1995-11-27 under 510(k) number K954929. 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 SINGLE DOSE?

CHARISMA SINGLE DOSE is a medical device that received FDA 510(k) clearance on 1995-11-27. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K954929.

When did CHARISMA SINGLE DOSE receive FDA 510(k) clearance?

CHARISMA SINGLE DOSE received FDA 510(k) clearance on 1995-11-27, under 510(k) number K954929.

Who is the listed applicant for CHARISMA SINGLE DOSE?

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

What is the FDA product code for CHARISMA SINGLE DOSE?

The FDA product code for CHARISMA SINGLE DOSE is EBF.

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Other records listing Heraeus Kulzer, Inc. 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: EBF)

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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