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FDA 510(k)

MENIX®; MENIX® DUO

K-Number: K223122 · 2023-08-03

ApplicantS.B.M. Sas (Science & Bio Materials)
Decision Date2023-08-03
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MENIX®; MENIX® DUO is the device name listed in this FDA 510(k) record. The listed applicant is S.B.M. Sas (Science & Bio Materials). It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K223122. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENIX®; MENIX® DUO?

MENIX®; MENIX® DUO is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is S.B.M. Sas (Science & Bio Materials). The 510(k) number is K223122.

When did MENIX®; MENIX® DUO receive FDA 510(k) clearance?

MENIX®; MENIX® DUO received FDA 510(k) clearance on 2023-08-03, under 510(k) number K223122.

Who is the listed applicant for MENIX®; MENIX® DUO?

The FDA 510(k) record lists S.B.M. Sas (Science & Bio Materials) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MENIX®; MENIX® DUO?

The FDA product code for MENIX®; MENIX® DUO is GAT.

Other records listing S.B.M. Sas (Science & Bio Materials) as applicant

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Related Devices (Code: GAT)

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

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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