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FDA 510(k)

FAICO CMF System

K-Number: K191997 · 2020-04-22

ApplicantFaico Medical, LLC
Decision Date2020-04-22
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FAICO CMF System is a medical device manufactured by Faico Medical, LLC. It received FDA 510(k) clearance on 2020-04-22 under approval number K191997. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAICO CMF System?

FAICO CMF System is a medical device that received FDA 510(k) clearance on 2020-04-22. It is manufactured by Faico Medical, LLC. The 510(k) number is K191997.

When was FAICO CMF System approved by the FDA?

FAICO CMF System received FDA 510(k) clearance on 2020-04-22, under approval number K191997.

What company makes FAICO CMF System?

FAICO CMF System is manufactured by Faico Medical, LLC.

What is the FDA product code for FAICO CMF System?

The FDA product code for FAICO CMF System is JEY.

Other Devices by Faico Medical, LLC

K192015Faico Dental Implant System K211871FAICO Dental Implant System and CAD/CAM Abutments

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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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