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FDA 510(k)

Accordion Piccolo Stone Management Device

K 號:K172299 · 2017-09-19

決定日期2017-09-19
產品代碼FFL
諮詢委員會GU
決定相當於

器材摘要

Accordion Piccolo Stone Management Device is the device name listed in this FDA 510(k) record. The listed applicant is Ths International, Inc. D/B/A Accordion Medical. It received FDA 510(k) clearance on 2017-09-19 under 510(k) number K172299. The device is classified under product code FFL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Accordion Piccolo Stone Management Device?

Accordion Piccolo Stone Management Device is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Ths International, Inc. D/B/A Accordion Medical. The 510(k) number is K172299.

When did Accordion Piccolo Stone Management Device receive FDA 510(k) clearance?

Accordion Piccolo Stone Management Device received FDA 510(k) clearance on 2017-09-19, under 510(k) number K172299.

Who is the listed applicant for Accordion Piccolo Stone Management Device?

The FDA 510(k) record lists Ths International, Inc. D/B/A Accordion Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accordion Piccolo Stone Management Device?

The FDA product code for Accordion Piccolo Stone Management Device is FFL.

相關臨床試驗

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相關器械(代碼:FFL)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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