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FDA 510(k)

CODMAN DURAFORM DURAL GRAFT IMPLANT

K-Number: K041518 · 2004-06-22

ApplicantCodman & Shurtleff, Inc.
Decision Date2004-06-22
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CODMAN DURAFORM DURAL GRAFT IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2004-06-22 under 510(k) number K041518. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN DURAFORM DURAL GRAFT IMPLANT?

CODMAN DURAFORM DURAL GRAFT IMPLANT is a medical device that received FDA 510(k) clearance on 2004-06-22. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K041518.

When did CODMAN DURAFORM DURAL GRAFT IMPLANT receive FDA 510(k) clearance?

CODMAN DURAFORM DURAL GRAFT IMPLANT received FDA 510(k) clearance on 2004-06-22, under 510(k) number K041518.

Who is the listed applicant for CODMAN DURAFORM DURAL GRAFT IMPLANT?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CODMAN DURAFORM DURAL GRAFT IMPLANT?

The FDA product code for CODMAN DURAFORM DURAL GRAFT IMPLANT is GXQ.

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Related Devices (Code: GXQ)

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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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