FDA 510(k)

Kerecis矽膠

K 號：K213231 · 2022-06-29

決定日期2022-06-29

產品代碼KGN

決定相當於

器材摘要

Kerecis Silicone is the device name listed in this FDA 510(k) record. The listed applicant is Kerecis Limited. It received FDA 510(k) clearance on 2022-06-29 under 510(k) number K213231. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the Kerecis Silicone?

Kerecis Silicone is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Kerecis Limited. The 510(k) number is K213231.

When did Kerecis Silicone receive FDA 510(k) clearance?

Kerecis Silicone received FDA 510(k) clearance on 2022-06-29, under 510(k) number K213231.

Who is the listed applicant for Kerecis Silicone?

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

What is the FDA product code for Kerecis Silicone?

The FDA product code for Kerecis Silicone is KGN.

其他以 Kerecis Limited 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。

K251845馬日根傷口外用藥；凱瑞斯矽膠；凱瑞斯帕魯斯 K251844Kerecis SurgiBind (50241)K243843腱保護器（50242）K241080Kerecis Parvus (50207)K202430Kerecis 重構 K192612Kerecis 牙齦移植片

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相關器械（代碼：KGN）

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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