FDA 510(k)

SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL

K-Number: K063161 · 2006-11-21

Decision Date2006-11-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL 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 2006-11-21 under 510(k) number K063161. 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 SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL?

SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL is a medical device that received FDA 510(k) clearance on 2006-11-21. The listed applicant is Leonhard Lang GmbH. The 510(k) number is K063161.

When did SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL receive FDA 510(k) clearance?

SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL received FDA 510(k) clearance on 2006-11-21, under 510(k) number K063161.

Who is the listed applicant for SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL?

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 COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL?

The FDA product code for SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL 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.