FDA 510(k)

K3Pro Konus 新基台和植入物

K号: K190192 · 2020-02-10

申请人Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG

决定日期2020-02-10

产品代码DZE

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决定实质等同

器械摘要

K3Pro Konus New Abutments and Implants is the device name listed in this FDA 510(k) record. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. It received FDA 510(k) clearance on 2020-02-10 under 510(k) number K190192. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the K3Pro Konus New Abutments and Implants?

K3Pro Konus New Abutments and Implants is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. The 510(k) number is K190192.

When did K3Pro Konus New Abutments and Implants receive FDA 510(k) clearance?

K3Pro Konus New Abutments and Implants received FDA 510(k) clearance on 2020-02-10, under 510(k) number K190192.

Who is the listed applicant for K3Pro Konus New Abutments and Implants?

The FDA 510(k) record lists Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K3Pro Konus New Abutments and Implants?

The FDA product code for K3Pro Konus New Abutments and Implants is DZE.

列明Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG为申报人的其他记录

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