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FDA 510(k)

APEX ELECTRIC HANDPIECE SYSTEM

K-Number: K031540 · 2003-06-30

Decision Date2003-06-30
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APEX ELECTRIC HANDPIECE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lares Research, Inc.. It received FDA 510(k) clearance on 2003-06-30 under 510(k) number K031540. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX ELECTRIC HANDPIECE SYSTEM?

APEX ELECTRIC HANDPIECE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-30. The listed applicant is Lares Research, Inc.. The 510(k) number is K031540.

When did APEX ELECTRIC HANDPIECE SYSTEM receive FDA 510(k) clearance?

APEX ELECTRIC HANDPIECE SYSTEM received FDA 510(k) clearance on 2003-06-30, under 510(k) number K031540.

Who is the listed applicant for APEX ELECTRIC HANDPIECE SYSTEM?

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

What is the FDA product code for APEX ELECTRIC HANDPIECE SYSTEM?

The FDA product code for APEX ELECTRIC HANDPIECE SYSTEM is EKX.

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 Lares Research, 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.

View all 7 devices →

Related Devices (Code: EKX)

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.

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