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FDA 510(k)

HELIOFORM GOLD-BASED ALLOY

K-Number: K990670 · 1999-04-02

ApplicantC. Hafner GmbH & Co.
Decision Date1999-04-02
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HELIOFORM GOLD-BASED ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is C. Hafner GmbH & Co.. It received FDA 510(k) clearance on 1999-04-02 under 510(k) number K990670. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELIOFORM GOLD-BASED ALLOY?

HELIOFORM GOLD-BASED ALLOY is a medical device that received FDA 510(k) clearance on 1999-04-02. The listed applicant is C. Hafner GmbH & Co.. The 510(k) number is K990670.

When did HELIOFORM GOLD-BASED ALLOY receive FDA 510(k) clearance?

HELIOFORM GOLD-BASED ALLOY received FDA 510(k) clearance on 1999-04-02, under 510(k) number K990670.

Who is the listed applicant for HELIOFORM GOLD-BASED ALLOY?

The FDA 510(k) record lists C. Hafner GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HELIOFORM GOLD-BASED ALLOY?

The FDA product code for HELIOFORM GOLD-BASED ALLOY is EJT.

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Related Devices (Code: EJT)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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