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FDA 510(k)

KULZER INLAY SYSTEM

K-Number: K892454 · 1989-06-16

ApplicantKulzer, Inc.
Decision Date1989-06-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KULZER INLAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K892454. 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 KULZER INLAY SYSTEM?

KULZER INLAY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Kulzer, Inc.. The 510(k) number is K892454.

When did KULZER INLAY SYSTEM receive FDA 510(k) clearance?

KULZER INLAY SYSTEM received FDA 510(k) clearance on 1989-06-16, under 510(k) number K892454.

Who is the listed applicant for KULZER INLAY SYSTEM?

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

What is the FDA product code for KULZER INLAY SYSTEM?

The FDA product code for KULZER INLAY SYSTEM is EBF.

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Other records listing Kulzer, Inc. as applicant

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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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