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FDA 510(k)

Neo GBR System

K-Number: K160991 · 2017-01-10

ApplicantNeobiotech Co., Ltd.
Decision Date2017-01-10
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neo GBR System 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 2017-01-10 under 510(k) number K160991. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neo GBR System?

Neo GBR System is a medical device that received FDA 510(k) clearance on 2017-01-10. The listed applicant is Neobiotech Co., Ltd.. The 510(k) number is K160991.

When did Neo GBR System receive FDA 510(k) clearance?

Neo GBR System received FDA 510(k) clearance on 2017-01-10, under 510(k) number K160991.

Who is the listed applicant for Neo GBR System?

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 GBR System?

The FDA product code for Neo GBR System is DZL.

Other records listing Neobiotech Co., Ltd. as applicant

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Related Devices (Code: DZL)

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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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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