FDA 510(k)

PMSSteripack テイブック殺菌ポーチ（TP）およびロール（TY）および化学指示器

K番号: K160595 · 2016-11-18

申請者Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti

決定日2016-11-18

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

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K160595. 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 PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator?

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti. The 510(k) number is K160595.

When did PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator receive FDA 510(k) clearance?

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator received FDA 510(k) clearance on 2016-11-18, under 510(k) number K160595.

Who is the listed applicant for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator?

The FDA 510(k) record lists Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator?

The FDA product code for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator is FRG.

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。

PMSSteripack テイブック殺菌ポーチ（TP）およびロール（TY）および化学指示器

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FRG）

公式ソース