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FDA 510(k)

CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST

K-Number: K092773 · 2009-11-24

ApplicantTecres S.P.A.
Decision Date2009-11-24
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST is the device name listed in this FDA 510(k) record. The listed applicant is Tecres S.P.A.. It received FDA 510(k) clearance on 2009-11-24 under 510(k) number K092773. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST?

CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST is a medical device that received FDA 510(k) clearance on 2009-11-24. The listed applicant is Tecres S.P.A.. The 510(k) number is K092773.

When did CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST receive FDA 510(k) clearance?

CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST received FDA 510(k) clearance on 2009-11-24, under 510(k) number K092773.

Who is the listed applicant for CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST?

The FDA 510(k) record lists Tecres S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST?

The FDA product code for CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST is LOD.

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Other records listing Tecres S.P.A. as applicant

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Related Devices (Code: LOD)

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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