FDA 510(k)

Ultima HA 包覆半針及電纜

K 號：K163487 · 2017-02-13

決定日期2017-02-13

產品代碼JDW

諮詢委員會或

決定相當於

器材摘要

Ultima HA Coated Half Pins and Wire is the device name listed in this FDA 510(k) record. The listed applicant is Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2017-02-13 under 510(k) number K163487. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ultima HA Coated Half Pins and Wire?

Ultima HA Coated Half Pins and Wire is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Vilex IN Tennessee, Inc.. The 510(k) number is K163487.

When did Ultima HA Coated Half Pins and Wire receive FDA 510(k) clearance?

Ultima HA Coated Half Pins and Wire received FDA 510(k) clearance on 2017-02-13, under 510(k) number K163487.

Who is the listed applicant for Ultima HA Coated Half Pins and Wire?

The FDA 510(k) record lists Vilex IN Tennessee, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultima HA Coated Half Pins and Wire?

The FDA product code for Ultima HA Coated Half Pins and Wire is JDW.

其他以 Vilex IN Tennessee, Inc. 為申請人之記錄

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