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FDA 510(k)

DEFLEX ACRILATO

K-Number: K113788 · 2012-03-16

ApplicantNuxen S.R.L.
Decision Date2012-03-16
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEFLEX ACRILATO is the device name listed in this FDA 510(k) record. The listed applicant is Nuxen S.R.L.. It received FDA 510(k) clearance on 2012-03-16 under 510(k) number K113788. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEFLEX ACRILATO?

DEFLEX ACRILATO is a medical device that received FDA 510(k) clearance on 2012-03-16. The listed applicant is Nuxen S.R.L.. The 510(k) number is K113788.

When did DEFLEX ACRILATO receive FDA 510(k) clearance?

DEFLEX ACRILATO received FDA 510(k) clearance on 2012-03-16, under 510(k) number K113788.

Who is the listed applicant for DEFLEX ACRILATO?

The FDA 510(k) record lists Nuxen S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFLEX ACRILATO?

The FDA product code for DEFLEX ACRILATO is EBI.

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.

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Other records listing Nuxen S.R.L. 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.

K113608DEFLEX

Related Devices (Code: EBI)

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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