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FDA 510(k)

BIO-GIDE RESORBABLE BILAYER MEMBRANE

K-Number: K960724 · 1997-06-11

ApplicantGeistlich-Pharma
Decision Date1997-06-11
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-GIDE RESORBABLE BILAYER MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich-Pharma. It received FDA 510(k) clearance on 1997-06-11 under 510(k) number K960724. 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 BIO-GIDE RESORBABLE BILAYER MEMBRANE?

BIO-GIDE RESORBABLE BILAYER MEMBRANE is a medical device that received FDA 510(k) clearance on 1997-06-11. The listed applicant is Geistlich-Pharma. The 510(k) number is K960724.

When did BIO-GIDE RESORBABLE BILAYER MEMBRANE receive FDA 510(k) clearance?

BIO-GIDE RESORBABLE BILAYER MEMBRANE received FDA 510(k) clearance on 1997-06-11, under 510(k) number K960724.

Who is the listed applicant for BIO-GIDE RESORBABLE BILAYER MEMBRANE?

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

What is the FDA product code for BIO-GIDE RESORBABLE BILAYER MEMBRANE?

The FDA product code for BIO-GIDE RESORBABLE BILAYER MEMBRANE is NPK.

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Other records listing Geistlich-Pharma 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.

K033815BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGENK014289ORTHOSS RESORBABLE BONE VOID FILLERK970569BIO-BLOCKSK974399BIO-OSS COLLAGENK970321BIO-OSS ANORGANIC BOVINE BONEK972817RESOR-PIN RESORBABLE MEMBRANE PIN

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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

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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