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FDA 510(k)

TEFGEN - LS

K-Number: K965205 · 1997-04-30

ApplicantAmerican Custom Medical, Inc.
Decision Date1997-04-30
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEFGEN - LS 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 1997-04-30 under 510(k) number K965205. 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 - LS?

TEFGEN - LS is a medical device that received FDA 510(k) clearance on 1997-04-30. The listed applicant is American Custom Medical, Inc.. The 510(k) number is K965205.

When did TEFGEN - LS receive FDA 510(k) clearance?

TEFGEN - LS received FDA 510(k) clearance on 1997-04-30, under 510(k) number K965205.

Who is the listed applicant for TEFGEN - LS?

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 - LS?

The FDA product code for TEFGEN - LS 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.

K964656TEFGEN GUIDED TISSUE MEMBRANEK944413ACM 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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