FDA 510(k)

パックデントバリアスリーving、カバー・イット™バリアフィルム

K番号: K151123 · 2016-03-03

決定日2016-03-03

製品コードPEM

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent International, Inc.. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K151123. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film?

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Pac-Dent International, Inc.. The 510(k) number is K151123.

When did Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film receive FDA 510(k) clearance?

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film received FDA 510(k) clearance on 2016-03-03, under 510(k) number K151123.

Who is the listed applicant for Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film?

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

What is the FDA product code for Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film?

The FDA product code for Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film is PEM.

申請者としてPac-Dent International, Inc.を記載するその他の記録

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