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FDA 510(k)

TUTOPLAST DURA

K-Number: K910555 · 1992-04-20

ApplicantPfrimmer-Viggo GmbH & Co.
Decision Date1992-04-20
Product CodeLEM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TUTOPLAST DURA is the device name listed in this FDA 510(k) record. The listed applicant is Pfrimmer-Viggo GmbH & Co.. It received FDA 510(k) clearance on 1992-04-20 under 510(k) number K910555. The device is classified under product code LEM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUTOPLAST DURA?

TUTOPLAST DURA is a medical device that received FDA 510(k) clearance on 1992-04-20. The listed applicant is Pfrimmer-Viggo GmbH & Co.. The 510(k) number is K910555.

When did TUTOPLAST DURA receive FDA 510(k) clearance?

TUTOPLAST DURA received FDA 510(k) clearance on 1992-04-20, under 510(k) number K910555.

Who is the listed applicant for TUTOPLAST DURA?

The FDA 510(k) record lists Pfrimmer-Viggo GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TUTOPLAST DURA?

The FDA product code for TUTOPLAST DURA is LEM.

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Related Devices (Code: LEM)

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.

K910447DURA MATERLifelink Foundation Tissue Bank

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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