FDA 510(k)

自己密封消毒袋

K番号: K243721 · 2025-04-25

申請者Wellmed Dental Medical Supply Co., Ltd.

決定日2025-04-25

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

Self Sealing Sterilization Pouches is the device name listed in this FDA 510(k) record. The listed applicant is Wellmed Dental Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243721. 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 Self Sealing Sterilization Pouches?

Self Sealing Sterilization Pouches is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Wellmed Dental Medical Supply Co., Ltd.. The 510(k) number is K243721.

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

Self Sealing Sterilization Pouches received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243721.

Who is the listed applicant for Self Sealing Sterilization Pouches?

The FDA 510(k) record lists Wellmed Dental Medical Supply 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.

申請者としてWellmed Dental Medical Supply Co., Ltd.を記載するその他の記録

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公式ソース

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