FDA 510(k)

GalaFORM 3D

K 號：K162922 · 2017-02-23

決定日期2017-02-23

產品代碼OOD

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

GalaFORM 3D is the device name listed in this FDA 510(k) record. The listed applicant is Tepha, Inc.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K162922. The device is classified under product code OOD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GalaFORM 3D?

GalaFORM 3D is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Tepha, Inc.. The 510(k) number is K162922.

When did GalaFORM 3D receive FDA 510(k) clearance?

GalaFORM 3D received FDA 510(k) clearance on 2017-02-23, under 510(k) number K162922.

Who is the listed applicant for GalaFORM 3D?

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

What is the FDA product code for GalaFORM 3D?

The FDA product code for GalaFORM 3D is OOD.

其他以 Tepha, 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。

K233999GalaFLEX LITE 床架 K202425SurgiLattice 床架 K211307GalaSTITCH 可吸收單絲縫線 K161092GalaSHAPE 3D

相關器械（代碼：OOD）

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。

K233999GalaFLEX LITE 床架Tepha, Inc.K202425SurgiLattice 床架Tepha, Inc.K161424Phasix 網格C.R. Bard, Inc.K161092GalaSHAPE 3DTepha, Inc.

官方來源

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