• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K181643, SmartBag (SmartPouch), by 11 Health Technologies Limited

FDA 510(k) K181643, SmartBag (SmartPouch), by 11 Health Technologies Limited

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

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