FDA 510(k)

AOS間隙テンプレート、針、アクセサリー

K番号: K233628 · 2024-07-10

決定日2024-07-10

製品コードJAQ

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

AOS Interstitial Templates, Needles, and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Omega Services, Inc.. It received FDA 510(k) clearance on 2024-07-10 under 510(k) number K233628. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the AOS Interstitial Templates, Needles, and Accessories?

AOS Interstitial Templates, Needles, and Accessories is a medical device that received FDA 510(k) clearance on 2024-07-10. The listed applicant is Alpha-Omega Services, Inc.. The 510(k) number is K233628.

When did AOS Interstitial Templates, Needles, and Accessories receive FDA 510(k) clearance?

AOS Interstitial Templates, Needles, and Accessories received FDA 510(k) clearance on 2024-07-10, under 510(k) number K233628.

Who is the listed applicant for AOS Interstitial Templates, Needles, and Accessories?

The FDA 510(k) record lists Alpha-Omega Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AOS Interstitial Templates, Needles, and Accessories?

The FDA product code for AOS Interstitial Templates, Needles, and Accessories is JAQ.

申請者としてAlpha-Omega Services, Inc.を記載するその他の記録

K233626AOSマーカーセeds（SMG0242-025）

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