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FDA 510(k)

NTI CLENCHING SUPPRESSION SYSTEM

K-Number: K981546 · 1998-07-15

ApplicantHeraeus Kulzer, Inc.
Decision Date1998-07-15
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

NTI CLENCHING SUPPRESSION SYSTEM 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 1998-07-15 under 510(k) number K981546. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NTI CLENCHING SUPPRESSION SYSTEM?

NTI CLENCHING SUPPRESSION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-15. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K981546.

When did NTI CLENCHING SUPPRESSION SYSTEM receive FDA 510(k) clearance?

NTI CLENCHING SUPPRESSION SYSTEM received FDA 510(k) clearance on 1998-07-15, under 510(k) number K981546.

Who is the listed applicant for NTI CLENCHING SUPPRESSION SYSTEM?

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 NTI CLENCHING SUPPRESSION SYSTEM?

The FDA product code for NTI CLENCHING SUPPRESSION SYSTEM is MQC.

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Other records listing Heraeus Kulzer, Inc. as applicant

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Related Devices (Code: MQC)

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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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