FDA 510(k), K150852, SIC 8000
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)
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