FDA 510(k)

バリア・スプルーム・除菌包装材

K番号: K162162 · 2016-11-04

決定日2016-11-04

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Substantially Equivalent

医療機器の概要

Barrier Supreme Sterilization Wrapper is the device name listed in this FDA 510(k) record. The listed applicant is Standard Textile Co., Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162162. 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 Barrier Supreme Sterilization Wrapper?

Barrier Supreme Sterilization Wrapper is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Standard Textile Co., Inc.. The 510(k) number is K162162.

When did Barrier Supreme Sterilization Wrapper receive FDA 510(k) clearance?

Barrier Supreme Sterilization Wrapper received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162162.

Who is the listed applicant for Barrier Supreme Sterilization Wrapper?

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

What is the FDA product code for Barrier Supreme Sterilization Wrapper?

The FDA product code for Barrier Supreme Sterilization Wrapper is FRG.

申請者としてStandard Textile Co., Inc.を記載するその他の記録

K241214ProPel SG3™手術衣 K172207Standard Supreme Sterilization Wrapper

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。