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FDA 510(k)

Forma System, Forma Light System

K-Number: K160195 · 2016-04-15

ApplicantFormatk Systems , Ltd.
Decision Date2016-04-15
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Forma System, Forma Light System is a medical device manufactured by Formatk Systems , Ltd.. It received FDA 510(k) clearance on 2016-04-15 under approval number K160195. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Forma System, Forma Light System?

Forma System, Forma Light System is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Formatk Systems , Ltd.. The 510(k) number is K160195.

When was Forma System, Forma Light System approved by the FDA?

Forma System, Forma Light System received FDA 510(k) clearance on 2016-04-15, under approval number K160195.

What company makes Forma System, Forma Light System?

Forma System, Forma Light System is manufactured by Formatk Systems , Ltd..

What is the FDA product code for Forma System, Forma Light System?

The FDA product code for Forma System, Forma Light System is ONF.

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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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