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FDA 510(k)

DURA-PATCH MODEL DP-XXX

K-Number: K980548 · 1998-05-13

ApplicantBridger Biomed, Inc.
Decision Date1998-05-13
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DURA-PATCH MODEL DP-XXX is the device name listed in this FDA 510(k) record. The listed applicant is Bridger Biomed, Inc.. It received FDA 510(k) clearance on 1998-05-13 under 510(k) number K980548. 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 DURA-PATCH MODEL DP-XXX?

DURA-PATCH MODEL DP-XXX is a medical device that received FDA 510(k) clearance on 1998-05-13. The listed applicant is Bridger Biomed, Inc.. The 510(k) number is K980548.

When did DURA-PATCH MODEL DP-XXX receive FDA 510(k) clearance?

DURA-PATCH MODEL DP-XXX received FDA 510(k) clearance on 1998-05-13, under 510(k) number K980548.

Who is the listed applicant for DURA-PATCH MODEL DP-XXX?

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

What is the FDA product code for DURA-PATCH MODEL DP-XXX?

The FDA product code for DURA-PATCH MODEL DP-XXX is GXQ.

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Other records listing Bridger Biomed, Inc. as applicant

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.

K003906MODIFICATION TO FLUROTEX SURGICAL MESHK003917MODIFICATION TO FLUOROTEX II SURGICAL MESHK002351FLUOROTEX II SURGICAL MESHK994032FLUORO-TEX CARDIOVASCULAR PATCHK984197FLUOROTEX SURGICAL MESHK973178FLUORO-TEX SURGICAL MEMBRANE

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Related Devices (Code: GXQ)

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.

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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