FDA 510(k)

BioZorb 標記器 GOLD / LP 標記器 GOLD

K 號：K171467 · 2017-11-09

決定日期2017-11-09

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

BioZorb Marker GOLD / LP Marker GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Focal Therapeutics. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K171467. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioZorb Marker GOLD / LP Marker GOLD?

BioZorb Marker GOLD / LP Marker GOLD is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Focal Therapeutics. The 510(k) number is K171467.

When did BioZorb Marker GOLD / LP Marker GOLD receive FDA 510(k) clearance?

BioZorb Marker GOLD / LP Marker GOLD received FDA 510(k) clearance on 2017-11-09, under 510(k) number K171467.

Who is the listed applicant for BioZorb Marker GOLD / LP Marker GOLD?

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

What is the FDA product code for BioZorb Marker GOLD / LP Marker GOLD?

The FDA product code for BioZorb Marker GOLD / LP Marker GOLD is IYE.

其他以 Focal Therapeutics 為申請人之記錄

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。

K192371生物Zorb SP標記

相關器械（代碼：IYE）

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。

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官方來源

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