FDA 510(k)

Nanova 黏合劑

K 號：K171330 · 2017-09-08

決定日期2017-09-08

產品代碼EBC

諮詢委員會DE

決定相當於

器材摘要

Nanova Sealant is the device name listed in this FDA 510(k) record. The listed applicant is Nanova Biomaterials, Inc.. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K171330. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nanova Sealant?

Nanova Sealant is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Nanova Biomaterials, Inc.. The 510(k) number is K171330.

When did Nanova Sealant receive FDA 510(k) clearance?

Nanova Sealant received FDA 510(k) clearance on 2017-09-08, under 510(k) number K171330.

Who is the listed applicant for Nanova Sealant?

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

What is the FDA product code for Nanova Sealant?

The FDA product code for Nanova Sealant is EBC.

其他以 Nanova Biomaterials, Inc. 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。

K172977Nanova 2 齒科粘合劑步驟式鹽酸鹼洗，Nanova鹽酸鹼鹽酸鹼膠 K163672Nanova 螺旋釘縫合墊，Nanova 推入式縫合墊 K161174諾瓦干擾螺釘 K151943Vas-Q-Clip

相關器械（代碼：EBC）

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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