FDA 510(k)

RPM加強型聚四氟乙烯網

K 號：K171774 · 2017-10-19

決定日期2017-10-19

產品代碼NPK

諮詢委員會DE

決定相當於

器材摘要

RPM Reinforced PTFE Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Osteogenics Biomedical, Inc.. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K171774. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RPM Reinforced PTFE Mesh?

RPM Reinforced PTFE Mesh is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Osteogenics Biomedical, Inc.. The 510(k) number is K171774.

When did RPM Reinforced PTFE Mesh receive FDA 510(k) clearance?

RPM Reinforced PTFE Mesh received FDA 510(k) clearance on 2017-10-19, under 510(k) number K171774.

Who is the listed applicant for RPM Reinforced PTFE Mesh?

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

What is the FDA product code for RPM Reinforced PTFE Mesh?

The FDA product code for RPM Reinforced PTFE Mesh is NPK.

其他以 Osteogenics Biomedical, 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。

K201187細胞膠膠钛纖維強化聚四氟乙烯膠膜

相關器械（代碼：NPK）

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。

K221851Lumina-PTFE 鈦金屬Criteria Industria E Comercio DE Produtos Medicinais K222549開放式紗布Purgo Biologics, Inc.K211554InnoGenic 不吸收性薄膜Cowellmedi Co., Ltd.K210797生物-MEM Ti加強膠膜B&Medi Co., Ltd.K201187細胞膠膠钛纖維強化聚四氟乙烯膠膜Osteogenics Biomedical, Inc.K160493Cytosurg不吸收性PTFE膠膜，25mm x 30mm，Cytosurg不吸收性PTFE膠膜，12mm x 24mmSalvin Dental Specialties

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