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FDA 510(k)

Cool Renewal

K-Number: K161296 · 2016-07-06

ApplicantCool Renewal, LLC
Decision Date2016-07-06
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cool Renewal is a medical device manufactured by Cool Renewal, LLC. It received FDA 510(k) clearance on 2016-07-06 under approval number K161296. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cool Renewal?

Cool Renewal is a medical device that received FDA 510(k) clearance on 2016-07-06. It is manufactured by Cool Renewal, LLC. The 510(k) number is K161296.

When was Cool Renewal approved by the FDA?

Cool Renewal received FDA 510(k) clearance on 2016-07-06, under approval number K161296.

What company makes Cool Renewal?

Cool Renewal is manufactured by Cool Renewal, LLC.

What is the FDA product code for Cool Renewal?

The FDA product code for Cool Renewal is GEH.

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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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