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FDA 510(k)

ENDOPROSTHESIS SYSTEM, VARIO-HEAD

K-Number: K781735 · 1978-10-24

ApplicantWaldemar Link GmbH & Co. KG
Decision Date1978-10-24
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOPROSTHESIS SYSTEM, VARIO-HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781735. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPROSTHESIS SYSTEM, VARIO-HEAD?

ENDOPROSTHESIS SYSTEM, VARIO-HEAD is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K781735.

When did ENDOPROSTHESIS SYSTEM, VARIO-HEAD receive FDA 510(k) clearance?

ENDOPROSTHESIS SYSTEM, VARIO-HEAD received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781735.

Who is the listed applicant for ENDOPROSTHESIS SYSTEM, VARIO-HEAD?

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

What is the FDA product code for ENDOPROSTHESIS SYSTEM, VARIO-HEAD?

The FDA product code for ENDOPROSTHESIS SYSTEM, VARIO-HEAD is KWY.

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Other records listing Waldemar Link GmbH & Co. KG as applicant

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Related Devices (Code: KWY)

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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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