FDA 510(k)

滅菌袋および巻筒

K番号: K242898 · 2025-02-21

申請者Shanghai Jianzhong Medical Packaging Co., Ltd.

決定日2025-02-21

製品コードFRG

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Sterilization Pouches and Reels is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Jianzhong Medical Packaging Co., Ltd.. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K242898. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sterilization Pouches and Reels?

Sterilization Pouches and Reels is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Shanghai Jianzhong Medical Packaging Co., Ltd.. The 510(k) number is K242898.

When did Sterilization Pouches and Reels receive FDA 510(k) clearance?

Sterilization Pouches and Reels received FDA 510(k) clearance on 2025-02-21, under 510(k) number K242898.

Who is the listed applicant for Sterilization Pouches and Reels?

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

What is the FDA product code for Sterilization Pouches and Reels?

The FDA product code for Sterilization Pouches and Reels is FRG.

申請者としてShanghai Jianzhong Medical Packaging Co., Ltd.を記載するその他の記録

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