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FDA 510(k)

TANTALUM BEAD SET, MODEL P003175

K-Number: K090581 · 2009-08-21

ApplicantHalifax Biomedical, Inc.
Decision Date2009-08-21
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TANTALUM BEAD SET, MODEL P003175 is the device name listed in this FDA 510(k) record. The listed applicant is Halifax Biomedical, Inc.. It received FDA 510(k) clearance on 2009-08-21 under 510(k) number K090581. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANTALUM BEAD SET, MODEL P003175?

TANTALUM BEAD SET, MODEL P003175 is a medical device that received FDA 510(k) clearance on 2009-08-21. The listed applicant is Halifax Biomedical, Inc.. The 510(k) number is K090581.

When did TANTALUM BEAD SET, MODEL P003175 receive FDA 510(k) clearance?

TANTALUM BEAD SET, MODEL P003175 received FDA 510(k) clearance on 2009-08-21, under 510(k) number K090581.

Who is the listed applicant for TANTALUM BEAD SET, MODEL P003175?

The FDA 510(k) record lists Halifax Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TANTALUM BEAD SET, MODEL P003175?

The FDA product code for TANTALUM BEAD SET, MODEL P003175 is NEU.

Related Clinical Trials

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Other records listing Halifax Biomedical, Inc. 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.

K182880Halifax Imaging KitK121345SR SUITE 1.0K103417HALIFAX BIOMEDICAL TANATLUM BEAD SET

Related Devices (Code: NEU)

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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