FDA 510(k)

軟插式延長效期180天導管塞

K 號：K162361 · 2017-04-17

決定日期2017-04-17

產品代碼LZU

決定相當於

器材摘要

Soft Plug Extended Duration 180 Canalicular Plug is the device name listed in this FDA 510(k) record. The listed applicant is Oasis Medical, Inc.. It received FDA 510(k) clearance on 2017-04-17 under 510(k) number K162361. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

常見問題

What is the Soft Plug Extended Duration 180 Canalicular Plug?

Soft Plug Extended Duration 180 Canalicular Plug is a medical device that received FDA 510(k) clearance on 2017-04-17. The listed applicant is Oasis Medical, Inc.. The 510(k) number is K162361.

When did Soft Plug Extended Duration 180 Canalicular Plug receive FDA 510(k) clearance?

Soft Plug Extended Duration 180 Canalicular Plug received FDA 510(k) clearance on 2017-04-17, under 510(k) number K162361.

Who is the listed applicant for Soft Plug Extended Duration 180 Canalicular Plug?

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

What is the FDA product code for Soft Plug Extended Duration 180 Canalicular Plug?

The FDA product code for Soft Plug Extended Duration 180 Canalicular Plug is LZU.

其他以 Oasis Medical, 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。

K213988SOFT PLUG 延長使用時間 180 Tapered 管道栓

相關器械（代碼：LZU）

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。

K241229您好，eyes® 生物插頭Bio Optics Co., Ltd.K222164威薩恩醫療管狀釘塞Visant Medical, Inc.K213988SOFT PLUG 延長使用時間 180 Tapered 管道栓Oasis Medical, Inc.K190210眼淚池可溶解淚點栓Alphamed, Inc.K161673LacriPro 眼淚點塞子Lacrimedics, Inc.

官方來源

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