FDA 510(k)

PriMatrix 皮膚修復支架

K 號：K153690 · 2016-02-22

決定日期2016-02-22

產品代碼KGN

決定相當於

器材摘要

PriMatrix Dermal Repair Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Tei Biosciences, Inc.. It received FDA 510(k) clearance on 2016-02-22 under 510(k) number K153690. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the PriMatrix Dermal Repair Scaffold?

PriMatrix Dermal Repair Scaffold is a medical device that received FDA 510(k) clearance on 2016-02-22. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K153690.

When did PriMatrix Dermal Repair Scaffold receive FDA 510(k) clearance?

PriMatrix Dermal Repair Scaffold received FDA 510(k) clearance on 2016-02-22, under 510(k) number K153690.

Who is the listed applicant for PriMatrix Dermal Repair Scaffold?

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

What is the FDA product code for PriMatrix Dermal Repair Scaffold?

The FDA product code for PriMatrix Dermal Repair Scaffold is KGN.

其他以 Tei Biosciences, 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。

K162965SurgiMend MP 软組織重建用膠原膠質

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。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 外科維網，1cc（CG-01AP）；Accelagen Plus 外科維網，3cc（CG-03AP）；Accelagen Plus 外科維網，5cc（CG-05AP）；Accelagen Plus 外科條，125x25x2mm（CG-125X25AP）；Accelagen Plus 外科條，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596膠原蛋白傷口粉末Ventris Medical K260669Endoform皮膚模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMD 医療設備規範文本翻譯： ECMT-100 WMD 医療設備規範文本Ecm Therapeutics, Inc.K253204催化BioTissue Holdings, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。