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FDA 510(k)

Plasma Shield

K-Number: K221533 · 2022-09-12

ApplicantPlasmatica, Ltd.
Decision Date2022-09-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Plasma Shield is a medical device manufactured by Plasmatica, Ltd.. It received FDA 510(k) clearance on 2022-09-12 under approval number K221533. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Plasma Shield?

Plasma Shield is a medical device that received FDA 510(k) clearance on 2022-09-12. It is manufactured by Plasmatica, Ltd.. The 510(k) number is K221533.

When was Plasma Shield approved by the FDA?

Plasma Shield received FDA 510(k) clearance on 2022-09-12, under approval number K221533.

What company makes Plasma Shield?

Plasma Shield is manufactured by Plasmatica, Ltd..

What is the FDA product code for Plasma Shield?

The FDA product code for Plasma Shield is GCJ.

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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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