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FDA 510(k)

BIOMESH BIODEGRADABLE GTR BARRIER

K-Number: K990363 · 1999-04-09

ApplicantSamyang Corp.
Decision Date1999-04-09
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOMESH BIODEGRADABLE GTR BARRIER is the device name listed in this FDA 510(k) record. The listed applicant is Samyang Corp.. It received FDA 510(k) clearance on 1999-04-09 under 510(k) number K990363. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMESH BIODEGRADABLE GTR BARRIER?

BIOMESH BIODEGRADABLE GTR BARRIER is a medical device that received FDA 510(k) clearance on 1999-04-09. The listed applicant is Samyang Corp.. The 510(k) number is K990363.

When did BIOMESH BIODEGRADABLE GTR BARRIER receive FDA 510(k) clearance?

BIOMESH BIODEGRADABLE GTR BARRIER received FDA 510(k) clearance on 1999-04-09, under 510(k) number K990363.

Who is the listed applicant for BIOMESH BIODEGRADABLE GTR BARRIER?

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

What is the FDA product code for BIOMESH BIODEGRADABLE GTR BARRIER?

The FDA product code for BIOMESH BIODEGRADABLE GTR BARRIER is NPK.

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Other records listing Samyang Corp. 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.

K984374SURGISORB

Related Devices (Code: NPK)

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.

K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos MedicinaisK222549OpenTexPurgo Biologics, Inc.K211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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