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FDA 510(k)

NEO TITANIUM MESH, CTI-MEM

K-Number: K111761 · 2012-01-10

Decision Date2012-01-10
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEO TITANIUM MESH, CTI-MEM is the device name listed in this FDA 510(k) record. The listed applicant is Neobiotech Co., Ltd.. It received FDA 510(k) clearance on 2012-01-10 under 510(k) number K111761. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO TITANIUM MESH, CTI-MEM?

NEO TITANIUM MESH, CTI-MEM is a medical device that received FDA 510(k) clearance on 2012-01-10. The listed applicant is Neobiotech Co., Ltd.. The 510(k) number is K111761.

When did NEO TITANIUM MESH, CTI-MEM receive FDA 510(k) clearance?

NEO TITANIUM MESH, CTI-MEM received FDA 510(k) clearance on 2012-01-10, under 510(k) number K111761.

Who is the listed applicant for NEO TITANIUM MESH, CTI-MEM?

The FDA 510(k) record lists Neobiotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEO TITANIUM MESH, CTI-MEM?

The FDA product code for NEO TITANIUM MESH, CTI-MEM is JEY.

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.

Other records listing Neobiotech Co., Ltd. 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.

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Related Devices (Code: JEY)

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.

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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