FDA 510(k)

NEUN

K-Number: K073554 · 2008-02-04

Decision Date2008-02-04

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

NEUN is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer,GmbH. It received FDA 510(k) clearance on 2008-02-04 under 510(k) number K073554. 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 NEUN?

NEUN is a medical device that received FDA 510(k) clearance on 2008-02-04. The listed applicant is Heraeus Kulzer,GmbH. The 510(k) number is K073554.

When did NEUN receive FDA 510(k) clearance?

NEUN received FDA 510(k) clearance on 2008-02-04, under 510(k) number K073554.

Who is the listed applicant for NEUN?

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

What is the FDA product code for NEUN?

The FDA product code for NEUN is EBF.

Other records listing Heraeus Kulzer,GmbH as applicant

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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.