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FDA 510(k)

CODMAN ETHISORB DURA PATCH

K-Number: K991413 · 2000-03-13

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date2000-03-13
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CODMAN ETHISORB DURA PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 2000-03-13 under 510(k) number K991413. 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 ETHISORB DURA PATCH?

CODMAN ETHISORB DURA PATCH is a medical device that received FDA 510(k) clearance on 2000-03-13. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K991413.

When did CODMAN ETHISORB DURA PATCH receive FDA 510(k) clearance?

CODMAN ETHISORB DURA PATCH received FDA 510(k) clearance on 2000-03-13, under 510(k) number K991413.

Who is the listed applicant for CODMAN ETHISORB DURA PATCH?

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

What is the FDA product code for CODMAN ETHISORB DURA PATCH?

The FDA product code for CODMAN ETHISORB DURA PATCH is GXQ.

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Other records listing Johnson & Johnson Professionals, Inc. as applicant

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Related Devices (Code: GXQ)

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K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.K172603Cerafix Dura SubstituteAcera Surgical, Inc.

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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