Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TENDER FIBER

K-Number: K063170 · 2007-01-12

Decision Date2007-01-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TENDER FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Micerium S.P.A.. It received FDA 510(k) clearance on 2007-01-12 under 510(k) number K063170. 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 TENDER FIBER?

TENDER FIBER is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is Micerium S.P.A.. The 510(k) number is K063170.

When did TENDER FIBER receive FDA 510(k) clearance?

TENDER FIBER received FDA 510(k) clearance on 2007-01-12, under 510(k) number K063170.

Who is the listed applicant for TENDER FIBER?

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

What is the FDA product code for TENDER FIBER?

The FDA product code for TENDER FIBER 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.

Other records listing Micerium S.P.A. 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: 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.

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.

↑