Blue Beacon Submucosal Injectable Solution— 510(k) K200071

Name: FDA 510(k) clearance K200071
Creator: U.S. Food and Drug Administration
Published: 2020-11-03

Substantially Equivalent

Micro-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K200071 for Blue Beacon Submucosal Injectable Solution, Substantially Equivalent on 2020-11-03. Applicant: Micro-Tech (Nanjing) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Code PLL
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-01-13
Decision date: 2020-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

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