FDA 510(k)

一次性醫療設備自封密閉消毒袋，一次性醫療設備消毒卷筒袋

K 號：K183356 · 2019-08-19

申請人Weihai Xingtai Packaging Products Co., Ltd.

決定日期2019-08-19

產品代碼FRG

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Weihai Xingtai Packaging Products Co., Ltd.. It received FDA 510(k) clearance on 2019-08-19 under 510(k) number K183356. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch?

Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch is a medical device that received FDA 510(k) clearance on 2019-08-19. The listed applicant is Weihai Xingtai Packaging Products Co., Ltd.. The 510(k) number is K183356.

When did Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch receive FDA 510(k) clearance?

Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch received FDA 510(k) clearance on 2019-08-19, under 510(k) number K183356.

Who is the listed applicant for Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch?

The FDA 510(k) record lists Weihai Xingtai Packaging Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch?

The FDA product code for Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch is FRG.

其他以 Weihai Xingtai Packaging Products Co., Ltd. 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。

K193561可抛弃式醫療設備自封閉消毒膠囊，可抛弃式醫療設備消毒卷筒膠囊

相關器械（代碼：FRG）

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。

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