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FDA 510(k)

ALLFIM IMPLANT SYSTEMS

K-Number: K050635 · 2005-07-28

ApplicantCowellmedi Co., Ltd.
Decision Date2005-07-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALLFIM IMPLANT SYSTEMS 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 2005-07-28 under 510(k) number K050635. 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 ALLFIM IMPLANT SYSTEMS?

ALLFIM IMPLANT SYSTEMS is a medical device that received FDA 510(k) clearance on 2005-07-28. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K050635.

When did ALLFIM IMPLANT SYSTEMS receive FDA 510(k) clearance?

ALLFIM IMPLANT SYSTEMS received FDA 510(k) clearance on 2005-07-28, under 510(k) number K050635.

Who is the listed applicant for ALLFIM IMPLANT SYSTEMS?

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 ALLFIM IMPLANT SYSTEMS?

The FDA product code for ALLFIM IMPLANT SYSTEMS is DZE.

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Other records listing Cowellmedi Co., Ltd. as applicant

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Related Devices (Code: DZE)

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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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