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FDA 510(k)

Synergy Marble (Model: Opasm)

K-Number: K220064 · 2022-07-22

ApplicantYrs Group, Inc.
Decision Date2022-07-22
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Synergy Marble (Model: Opasm) is a medical device manufactured by Yrs Group, Inc.. It received FDA 510(k) clearance on 2022-07-22 under approval number K220064. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synergy Marble (Model: Opasm)?

Synergy Marble (Model: Opasm) is a medical device that received FDA 510(k) clearance on 2022-07-22. It is manufactured by Yrs Group, Inc.. The 510(k) number is K220064.

When was Synergy Marble (Model: Opasm) approved by the FDA?

Synergy Marble (Model: Opasm) received FDA 510(k) clearance on 2022-07-22, under approval number K220064.

What company makes Synergy Marble (Model: Opasm)?

Synergy Marble (Model: Opasm) is manufactured by Yrs Group, Inc..

What is the FDA product code for Synergy Marble (Model: Opasm)?

The FDA product code for Synergy Marble (Model: Opasm) is OHS.

Other Devices by Yrs Group, Inc.

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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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