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FDA 510(k)

TBR IDEA CONIC/CONIC

K-Number: K050956 · 2006-02-16

ApplicantSudimplant SA
Decision Date2006-02-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TBR IDEA CONIC/CONIC is the device name listed in this FDA 510(k) record. The listed applicant is Sudimplant SA. It received FDA 510(k) clearance on 2006-02-16 under 510(k) number K050956. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBR IDEA CONIC/CONIC?

TBR IDEA CONIC/CONIC is a medical device that received FDA 510(k) clearance on 2006-02-16. The listed applicant is Sudimplant SA. The 510(k) number is K050956.

When did TBR IDEA CONIC/CONIC receive FDA 510(k) clearance?

TBR IDEA CONIC/CONIC received FDA 510(k) clearance on 2006-02-16, under 510(k) number K050956.

Who is the listed applicant for TBR IDEA CONIC/CONIC?

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

What is the FDA product code for TBR IDEA CONIC/CONIC?

The FDA product code for TBR IDEA CONIC/CONIC is DZE.

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 Sudimplant SA 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.

Related Devices (Code: DZE)

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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