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FDA 510(k)

SHELHIGH NO-REACT DURA SHIELD

K-Number: K982101 · 2000-05-02

ApplicantShelhigh, Inc.
Decision Date2000-05-02
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SHELHIGH NO-REACT DURA SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Shelhigh, Inc.. It received FDA 510(k) clearance on 2000-05-02 under 510(k) number K982101. 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 SHELHIGH NO-REACT DURA SHIELD?

SHELHIGH NO-REACT DURA SHIELD is a medical device that received FDA 510(k) clearance on 2000-05-02. The listed applicant is Shelhigh, Inc.. The 510(k) number is K982101.

When did SHELHIGH NO-REACT DURA SHIELD receive FDA 510(k) clearance?

SHELHIGH NO-REACT DURA SHIELD received FDA 510(k) clearance on 2000-05-02, under 510(k) number K982101.

Who is the listed applicant for SHELHIGH NO-REACT DURA SHIELD?

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

What is the FDA product code for SHELHIGH NO-REACT DURA SHIELD?

The FDA product code for SHELHIGH NO-REACT DURA SHIELD is GXQ.

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Other records listing Shelhigh, 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.

K032893SHELHIGH NO-REACT BIOCUFFK023940SHELHIGH BIORINGK991567SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.K982810SHELHIGH NO-REACT VASCUPATCHK981756SHELHIGH NO-REACT PNEUMOPLEDGETSK974914SHELHIGH NO-REACT PERICARDIAL PATCHES

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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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