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FDA 510(k)

SUGLUE-10

K-Number: K110508 · 2011-06-03

Applicant3M Espe AG
Decision Date2011-06-03
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUGLUE-10 is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe AG. It received FDA 510(k) clearance on 2011-06-03 under 510(k) number K110508. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUGLUE-10?

SUGLUE-10 is a medical device that received FDA 510(k) clearance on 2011-06-03. The listed applicant is 3M Espe AG. The 510(k) number is K110508.

When did SUGLUE-10 receive FDA 510(k) clearance?

SUGLUE-10 received FDA 510(k) clearance on 2011-06-03, under 510(k) number K110508.

Who is the listed applicant for SUGLUE-10?

The FDA 510(k) record lists 3M Espe AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUGLUE-10?

The FDA product code for SUGLUE-10 is EMA.

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Other records listing 3M Espe AG 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.

K120011HEISENBERG EFFECT SHADESK110302ADHESIVE EXL-759K111257HEISENBERG DYEING LIQUIDS

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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