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FDA 510(k)

DURAGEN PLUS DURAL GRAFT MATRIX

K-Number: K032693 · 2003-09-30

ApplicantIntegra Lifesciences Corp.
Decision Date2003-09-30
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DURAGEN PLUS DURAL GRAFT MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2003-09-30 under 510(k) number K032693. 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 DURAGEN PLUS DURAL GRAFT MATRIX?

DURAGEN PLUS DURAL GRAFT MATRIX is a medical device that received FDA 510(k) clearance on 2003-09-30. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K032693.

When did DURAGEN PLUS DURAL GRAFT MATRIX receive FDA 510(k) clearance?

DURAGEN PLUS DURAL GRAFT MATRIX received FDA 510(k) clearance on 2003-09-30, under 510(k) number K032693.

Who is the listed applicant for DURAGEN PLUS DURAL GRAFT MATRIX?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURAGEN PLUS DURAL GRAFT MATRIX?

The FDA product code for DURAGEN PLUS DURAL GRAFT MATRIX 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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