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FDA 510(k)

DIOSLIMON IMPLANT SYSTEM

K-Number: K112746 · 2011-10-21

ApplicantDio Corporation
Decision Date2011-10-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIOSLIMON IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2011-10-21 under 510(k) number K112746. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIOSLIMON IMPLANT SYSTEM?

DIOSLIMON IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-21. The listed applicant is Dio Corporation. The 510(k) number is K112746.

When did DIOSLIMON IMPLANT SYSTEM receive FDA 510(k) clearance?

DIOSLIMON IMPLANT SYSTEM received FDA 510(k) clearance on 2011-10-21, under 510(k) number K112746.

Who is the listed applicant for DIOSLIMON IMPLANT SYSTEM?

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

What is the FDA product code for DIOSLIMON IMPLANT SYSTEM?

The FDA product code for DIOSLIMON IMPLANT SYSTEM is DZE.

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Other records listing Dio Corporation as applicant

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Related Devices (Code: DZE)

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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