Kerecis 口腔
K 號：K213904 · 2022-09-30
廣告
器材摘要
Kerecis Oral is the device name listed in this FDA 510(k) record. The listed applicant is Kerecis. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K213904. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Kerecis Oral?
Kerecis Oral is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Kerecis. The 510(k) number is K213904.
When did Kerecis Oral receive FDA 510(k) clearance?
Kerecis Oral received FDA 510(k) clearance on 2022-09-30, under 510(k) number K213904.
Who is the listed applicant for Kerecis Oral?
The FDA 510(k) record lists Kerecis as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kerecis Oral?
The FDA product code for Kerecis Oral is NPL.
相關臨床試驗
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。
相關器械（代碼：NPL）
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。
K242817賈森膠膜Botiss Biomaterials GmbHK250512增強牙齦基質Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® 密封劑；Geistlich Fibro-Gide®Geistlich Pharma AGK251062Geistlich Bio-Gide；Geistlich Bio-Gide® Shape；Geistlich Bio-Gide® Compressed；Geistlich Bio-Gide® Forte；Geistlich Bio-Gide® Perio；Geistlich Combi-Kit Collagen®；Geistlich Perio-System Combi PackGeistlich Pharma AGK250833瑞士膠膜 X；瑞士膠膜 X 插孔Geistlich Pharma AGK233203軟組織增強可吸收網格Collagen Matrix, 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。
廣告