FDA 510(k) Applications for Medical Device Product Code "OWP"

FDA 510(k) Number Applicant Device Name Decision Date
K162701 STERIS CORPORATION VERIFY Assert Self-Contained Biological Indicator 03/24/2017
K181442 STERIS Corporation VERIFY Assert Self-Contained Biological Indicator 06/13/2018
K162945 STERIS Corporation VERIFY ASSERT STEAM Process Challenge Device 04/28/2017
DEN110006 STERIS Corporation VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR 07/12/2013
K163587 STERIS Corporation VERIFY Incubator for Assert Self Contained Biological Indicators 03/24/2017


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact