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FDA 510(k)

WOLFF SYSTEM

K-Number: K800896 · 1980-05-30

ApplicantWolff System GmbH
Decision Date1980-05-30
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WOLFF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wolff System GmbH. It received FDA 510(k) clearance on 1980-05-30 under 510(k) number K800896. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WOLFF SYSTEM?

WOLFF SYSTEM is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Wolff System GmbH. The 510(k) number is K800896.

When did WOLFF SYSTEM receive FDA 510(k) clearance?

WOLFF SYSTEM received FDA 510(k) clearance on 1980-05-30, under 510(k) number K800896.

Who is the listed applicant for WOLFF SYSTEM?

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

What is the FDA product code for WOLFF SYSTEM?

The FDA product code for WOLFF SYSTEM is LEJ.

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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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