FDA 510(k)

自封式消毒袋

K 號：K162258 · 2017-04-28

申請人Tianchang Jiarui Packaging Material Co., Ltd.

決定日期2017-04-28

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

Self Sealing Sterilization Pouches is the device name listed in this FDA 510(k) record. The listed applicant is Tianchang Jiarui Packaging Material Co., Ltd.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K162258. 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 Self Sealing Sterilization Pouches?

Self Sealing Sterilization Pouches is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Tianchang Jiarui Packaging Material Co., Ltd.. The 510(k) number is K162258.

When did Self Sealing Sterilization Pouches receive FDA 510(k) clearance?

Self Sealing Sterilization Pouches received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162258.

Who is the listed applicant for Self Sealing Sterilization Pouches?

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

What is the FDA product code for Self Sealing Sterilization Pouches?

The FDA product code for Self Sealing Sterilization Pouches is FRG.

其他以 Tianchang Jiarui Packaging Material Co., Ltd. 為申請人之記錄

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相關器械（代碼：FRG）

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