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FDA 510(k)

TEFGEN GUIDED TISSUE MEMBRANE

K-Number: K964656 · 1997-02-10

ApplicantAmerican Custom Medical, Inc.
Decision Date1997-02-10
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEFGEN GUIDED TISSUE MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is American Custom Medical, Inc.. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K964656. 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 TEFGEN GUIDED TISSUE MEMBRANE?

TEFGEN GUIDED TISSUE MEMBRANE is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is American Custom Medical, Inc.. The 510(k) number is K964656.

When did TEFGEN GUIDED TISSUE MEMBRANE receive FDA 510(k) clearance?

TEFGEN GUIDED TISSUE MEMBRANE received FDA 510(k) clearance on 1997-02-10, under 510(k) number K964656.

Who is the listed applicant for TEFGEN GUIDED TISSUE MEMBRANE?

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

What is the FDA product code for TEFGEN GUIDED TISSUE MEMBRANE?

The FDA product code for TEFGEN GUIDED TISSUE MEMBRANE is NPK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Custom Medical, 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.

K965205TEFGEN - LSK944413ACM PTFE SURGICAL MESHK935137TEFGEN-FDK933800FLUOROFILM(R)

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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