FDA 510(k), K150852, SIC 8000

510(K) Number: K150852
Device Name: SIC 8000
Manufacturer: COSMO TECHNOLOGIES, LTD.
Device Classification Name: submucosal injection agent
Regulation Number: 876.1500
Classification Product Code: PLL
Date Received: 03/31/2015
Decision Date: 09/03/2015
Regulation Medical Specialty: Gastroenterology/Urology

542 pages (2,260 of 2,802 original pages are fully redacted)