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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 the device name listed in this FDA 510(k) record. The listed applicant is Yrs Group, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) 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. The listed applicant is Yrs Group, Inc.. The 510(k) number is K220064.

When did Synergy Marble (Model: Opasm) receive FDA 510(k) clearance?

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

Who is the listed applicant for Synergy Marble (Model: Opasm)?

The FDA 510(k) record lists Yrs Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Yrs Group, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210954Synergy

Related Devices (Code: OHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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