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FDA 510(k)

MERON APPLICATION CAPSULES

K-Number: K130421 · 2013-08-14

ApplicantVoco GmbH
Decision Date2013-08-14
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MERON APPLICATION CAPSULES is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2013-08-14 under 510(k) number K130421. 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 MERON APPLICATION CAPSULES?

MERON APPLICATION CAPSULES is a medical device that received FDA 510(k) clearance on 2013-08-14. The listed applicant is Voco GmbH. The 510(k) number is K130421.

When did MERON APPLICATION CAPSULES receive FDA 510(k) clearance?

MERON APPLICATION CAPSULES received FDA 510(k) clearance on 2013-08-14, under 510(k) number K130421.

Who is the listed applicant for MERON APPLICATION CAPSULES?

The FDA 510(k) record lists Voco GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MERON APPLICATION CAPSULES?

The FDA product code for MERON APPLICATION CAPSULES is EMA.

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Other records listing Voco GmbH 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.

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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

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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