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FDA 510(k)

LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE

K-Number: K953992 · 1995-10-23

ApplicantLmi Lightwave Medical Industries , Ltd.
Decision Date1995-10-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Lmi Lightwave Medical Industries , Ltd.. It received FDA 510(k) clearance on 1995-10-23 under 510(k) number K953992. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE?

LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE is a medical device that received FDA 510(k) clearance on 1995-10-23. The listed applicant is Lmi Lightwave Medical Industries , Ltd.. The 510(k) number is K953992.

When did LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE receive FDA 510(k) clearance?

LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE received FDA 510(k) clearance on 1995-10-23, under 510(k) number K953992.

Who is the listed applicant for LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE?

The FDA 510(k) record lists Lmi Lightwave Medical Industries , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE?

The FDA product code for LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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