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FDA 510(k)

IMTEC/BIOBARRIER MEMBRANE

K-Number: K974752 · 1998-03-03

ApplicantImtec Corp.
Decision Date1998-03-03
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMTEC/BIOBARRIER MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is Imtec Corp.. It received FDA 510(k) clearance on 1998-03-03 under 510(k) number K974752. 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 IMTEC/BIOBARRIER MEMBRANE?

IMTEC/BIOBARRIER MEMBRANE is a medical device that received FDA 510(k) clearance on 1998-03-03. The listed applicant is Imtec Corp.. The 510(k) number is K974752.

When did IMTEC/BIOBARRIER MEMBRANE receive FDA 510(k) clearance?

IMTEC/BIOBARRIER MEMBRANE received FDA 510(k) clearance on 1998-03-03, under 510(k) number K974752.

Who is the listed applicant for IMTEC/BIOBARRIER MEMBRANE?

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

What is the FDA product code for IMTEC/BIOBARRIER MEMBRANE?

The FDA product code for IMTEC/BIOBARRIER MEMBRANE is NPK.

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Other records listing Imtec 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.

K081653MDI MII ONE-PIECE IMPLANT, 2.9MMK081347ILUMA VISIONK072660ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114K053046ILUMA ORTHOCAT/DENTALCATK043226ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320K042289MDI ORTHO

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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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