FDA 510(k)

玻璃鎖套件，玻璃鎖粉末，玻璃鎖液體

K 號：K193388 · 2020-04-27

決定日期2020-04-27

產品代碼DYH

諮詢委員會DE

決定相當於

器材摘要

GlassLok Kits, GlassLok Powder, GlassLok Liquid is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K193388. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GlassLok Kits, GlassLok Powder, GlassLok Liquid?

GlassLok Kits, GlassLok Powder, GlassLok Liquid is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K193388.

When did GlassLok Kits, GlassLok Powder, GlassLok Liquid receive FDA 510(k) clearance?

GlassLok Kits, GlassLok Powder, GlassLok Liquid received FDA 510(k) clearance on 2020-04-27, under 510(k) number K193388.

Who is the listed applicant for GlassLok Kits, GlassLok Powder, GlassLok Liquid?

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

What is the FDA product code for GlassLok Kits, GlassLok Powder, GlassLok Liquid?

The FDA product code for GlassLok Kits, GlassLok Powder, GlassLok Liquid is DYH.

其他以 Reliance Orthodontic Products, Inc. 為申請人之記錄

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相關器械（代碼：DYH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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