FDA 510(k)

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K 號：K241354 · 2024-08-27

決定日期2024-08-27

產品代碼KJJ

決定相當於

器材摘要

Sealer Solvent is the device name listed in this FDA 510(k) record. The listed applicant is Inter-Med, Inc.. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K241354. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

常見問題

What is the Sealer Solvent?

Sealer Solvent is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Inter-Med, Inc.. The 510(k) number is K241354.

When did Sealer Solvent receive FDA 510(k) clearance?

Sealer Solvent received FDA 510(k) clearance on 2024-08-27, under 510(k) number K241354.

Who is the listed applicant for Sealer Solvent?

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

What is the FDA product code for Sealer Solvent?

The FDA product code for Sealer Solvent is KJJ.

其他以 Inter-Med, 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。

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相關器械（代碼：KJJ）

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。

K250279RC-SwiftPrepBelport Company, Inc., Gingi-Pak K201785EPIEN 牙齒清潔器Epien Medical, Inc.K211813海神Inter-Med / Vista Dental K193357V-MixInter-Med/Vista Dental Products K193409視野清潔器，視野清潔器加強版Inter-Med/Vista Dental Products K200330RC-Prime根管準備膠膏Pac-Dent, Inc.

官方來源

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