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FDA 510(k)

CHARISMA -- MODIFIED

K-Number: K932013 · 1993-07-08

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-07-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHARISMA -- MODIFIED 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 1993-07-08 under 510(k) number K932013. 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 -- MODIFIED?

CHARISMA -- MODIFIED is a medical device that received FDA 510(k) clearance on 1993-07-08. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K932013.

When did CHARISMA -- MODIFIED receive FDA 510(k) clearance?

CHARISMA -- MODIFIED received FDA 510(k) clearance on 1993-07-08, under 510(k) number K932013.

Who is the listed applicant for CHARISMA -- MODIFIED?

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 -- MODIFIED?

The FDA product code for CHARISMA -- MODIFIED 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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