FDA 510(k)

M/L-10 クリップアプライアー消毒トレイ（カタログNo.3706）

K番号: K152743 · 2016-02-08

決定日2016-02-08

製品コードKCT

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

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) is the device name listed in this FDA 510(k) record. The listed applicant is Microline Surgical, Inc.. It received FDA 510(k) clearance on 2016-02-08 under 510(k) number K152743. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)?

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) is a medical device that received FDA 510(k) clearance on 2016-02-08. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K152743.

When did M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) receive FDA 510(k) clearance?

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) received FDA 510(k) clearance on 2016-02-08, under 510(k) number K152743.

Who is the listed applicant for M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)?

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

What is the FDA product code for M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)?

The FDA product code for M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) is KCT.

申請者としてMicroline Surgical, Inc.を記載するその他の記録

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