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FDA 510(k)

COSEAL

K-Number: K131411 · 2013-09-26

ApplicantJilin Coronado Medical , Ltd.
Decision Date2013-09-26
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COSEAL is the device name listed in this FDA 510(k) record. The listed applicant is Jilin Coronado Medical , Ltd.. It received FDA 510(k) clearance on 2013-09-26 under 510(k) number K131411. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSEAL?

COSEAL is a medical device that received FDA 510(k) clearance on 2013-09-26. The listed applicant is Jilin Coronado Medical , Ltd.. The 510(k) number is K131411.

When did COSEAL receive FDA 510(k) clearance?

COSEAL received FDA 510(k) clearance on 2013-09-26, under 510(k) number K131411.

Who is the listed applicant for COSEAL?

The FDA 510(k) record lists Jilin Coronado Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COSEAL?

The FDA product code for COSEAL is DXC.

Related Clinical Trials

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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Other records listing Jilin Coronado Medical , Ltd. 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.

K131124COLIGN

Related Devices (Code: DXC)

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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