FDA 510(k), K200071, Blue Beacon Submucosal Injectable Solution

510(K) Number: K200071
Device Name: Blue Beacon Submucosal Injectable Solution
Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
Device Classification Name: submucosal injection agent
Regulation Number: 876.1500
Classification Product Code: PLL
Date Received: 01/13/2020
Decision Date: 11/03/2020
Regulation Medical Specialty: Gastroenterology/Urology

213 pages (1,007 of 1,220 original pages are fully redacted)