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FDA 510(k)

COWELL IMPLANT SYSTEM

K-Number: K100850 · 2010-12-20

ApplicantCowellmedi Co., Ltd.
Decision Date2010-12-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COWELL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2010-12-20 under 510(k) number K100850. 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 COWELL IMPLANT SYSTEM?

COWELL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-20. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K100850.

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

COWELL IMPLANT SYSTEM received FDA 510(k) clearance on 2010-12-20, under 510(k) number K100850.

Who is the listed applicant for COWELL IMPLANT SYSTEM?

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

What is the FDA product code for COWELL IMPLANT SYSTEM?

The FDA product code for COWELL IMPLANT SYSTEM is DZE.

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Other records listing Cowellmedi Co., Ltd. as applicant

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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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