FDA 510(k)

Bucked Stride矽膠潤滑劑，#LubeLife薄型矽膠潤滑劑，JO XTRA SILKY超薄型矽膠個人潤滑劑

K 號：K190858 · 2019-09-18

決定日期2019-09-18

產品代碼NUC

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is United Consortium. It received FDA 510(k) clearance on 2019-09-18 under 510(k) number K190858. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant?

Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is United Consortium. The 510(k) number is K190858.

When did Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant receive FDA 510(k) clearance?

Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant received FDA 510(k) clearance on 2019-09-18, under 510(k) number K190858.

Who is the listed applicant for Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant?

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

What is the FDA product code for Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant?

The FDA product code for Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is NUC.