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FDA 510(k)

SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21

K-Number: K041883 · 2004-09-07

ApplicantLeonhard Lang GmbH
Decision Date2004-09-07
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 is the device name listed in this FDA 510(k) record. The listed applicant is Leonhard Lang GmbH. It received FDA 510(k) clearance on 2004-09-07 under 510(k) number K041883. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21?

SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 is a medical device that received FDA 510(k) clearance on 2004-09-07. The listed applicant is Leonhard Lang GmbH. The 510(k) number is K041883.

When did SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 receive FDA 510(k) clearance?

SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 received FDA 510(k) clearance on 2004-09-07, under 510(k) number K041883.

Who is the listed applicant for SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21?

The FDA 510(k) record lists Leonhard Lang GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21?

The FDA product code for SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 is MKJ. This falls under the Dental category.

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Other records listing Leonhard Lang GmbH 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.

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Related Devices (Code: MKJ)

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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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