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FDA 510(k)

ATLAS IMPLANT SYSTEM- MINI PLUS

K-Number: K090049 · 2009-04-20

ApplicantCowellmedi Co., Ltd.
Decision Date2009-04-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLAS IMPLANT SYSTEM- MINI PLUS 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 2009-04-20 under 510(k) number K090049. 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 ATLAS IMPLANT SYSTEM- MINI PLUS?

ATLAS IMPLANT SYSTEM- MINI PLUS is a medical device that received FDA 510(k) clearance on 2009-04-20. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K090049.

When did ATLAS IMPLANT SYSTEM- MINI PLUS receive FDA 510(k) clearance?

ATLAS IMPLANT SYSTEM- MINI PLUS received FDA 510(k) clearance on 2009-04-20, under 510(k) number K090049.

Who is the listed applicant for ATLAS IMPLANT SYSTEM- MINI PLUS?

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 ATLAS IMPLANT SYSTEM- MINI PLUS?

The FDA product code for ATLAS IMPLANT SYSTEM- MINI PLUS is 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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