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FDA 510(k)

Prodigio Stain Powder

K-Number: K171167 · 2017-12-13

ApplicantOperart, LLC
Decision Date2017-12-13
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Prodigio Stain Powder is a medical device manufactured by Operart, LLC. It received FDA 510(k) clearance on 2017-12-13 under approval number K171167. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prodigio Stain Powder?

Prodigio Stain Powder is a medical device that received FDA 510(k) clearance on 2017-12-13. It is manufactured by Operart, LLC. The 510(k) number is K171167.

When was Prodigio Stain Powder approved by the FDA?

Prodigio Stain Powder received FDA 510(k) clearance on 2017-12-13, under approval number K171167.

What company makes Prodigio Stain Powder?

Prodigio Stain Powder is manufactured by Operart, LLC.

What is the FDA product code for Prodigio Stain Powder?

The FDA product code for Prodigio Stain Powder is EIH.

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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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