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FDA 510(k)

COOL-TEC ELECTRODES

K-Number: K002841 · 2000-12-08

ApplicantSeedling Enterprises., LLC
Decision Date2000-12-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOL-TEC ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Seedling Enterprises., LLC. It received FDA 510(k) clearance on 2000-12-08 under 510(k) number K002841. 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 COOL-TEC ELECTRODES?

COOL-TEC ELECTRODES is a medical device that received FDA 510(k) clearance on 2000-12-08. The listed applicant is Seedling Enterprises., LLC. The 510(k) number is K002841.

When did COOL-TEC ELECTRODES receive FDA 510(k) clearance?

COOL-TEC ELECTRODES received FDA 510(k) clearance on 2000-12-08, under 510(k) number K002841.

Who is the listed applicant for COOL-TEC ELECTRODES?

The FDA 510(k) record lists Seedling Enterprises., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOL-TEC ELECTRODES?

The FDA product code for COOL-TEC ELECTRODES is GEI.

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.

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Other records listing Seedling Enterprises., LLC 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.

K012033MULTIFUNCTION ENDOSCOPIC INSTRUMENTK010710SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODESK001723COOL-TEC ELECTRODES

Related Devices (Code: 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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