FDA 510(k)

恢復牙膏

K 號：K181965 · 2019-06-13

決定日期2019-06-13

產品代碼LBH

諮詢委員會DE

決定相當於

器材摘要

Restore Toothpaste is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Collins, Inc.. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K181965. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Restore Toothpaste?

Restore Toothpaste is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Dr. Collins, Inc.. The 510(k) number is K181965.

When did Restore Toothpaste receive FDA 510(k) clearance?

Restore Toothpaste received FDA 510(k) clearance on 2019-06-13, under 510(k) number K181965.

Who is the listed applicant for Restore Toothpaste?

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

What is the FDA product code for Restore Toothpaste?

The FDA product code for Restore Toothpaste is LBH.

其他以 Dr. Collins, Inc. 為申請人之記錄

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相關器械（代碼：LBH）

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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官方來源

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