FDA 510(k)

APTOS ネジ – ポリプロピレン手術縫合糸

K番号: K192953 · 2020-08-27

決定日2020-08-27

製品コードGAW

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

APTOS Threads – Polypropylene Surgical Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Aptos, LLC. It received FDA 510(k) clearance on 2020-08-27 under 510(k) number K192953. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the APTOS Threads – Polypropylene Surgical Sutures?

APTOS Threads – Polypropylene Surgical Sutures is a medical device that received FDA 510(k) clearance on 2020-08-27. The listed applicant is Aptos, LLC. The 510(k) number is K192953.

When did APTOS Threads – Polypropylene Surgical Sutures receive FDA 510(k) clearance?

APTOS Threads – Polypropylene Surgical Sutures received FDA 510(k) clearance on 2020-08-27, under 510(k) number K192953.

Who is the listed applicant for APTOS Threads – Polypropylene Surgical Sutures?

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

What is the FDA product code for APTOS Threads – Polypropylene Surgical Sutures?

The FDA product code for APTOS Threads – Polypropylene Surgical Sutures is GAW.

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APTOS ネジ – ポリプロピレン手術縫合糸

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GAW）

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