FDA 510(k), K181643, SmartBag (SmartPouch)

510(K) Number: K181643
Device Name: SmartBag (SmartPouch)
Manufacturer: Michael Seres
Device Classification Name: Collector, Ostomy
Regulation Number: EXB
Classification Product Code: 06/22/2018
Date Received: 11/16/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology

847 pages (908 of 1,755 original pages are fully redacted)