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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 30 of 57 Results
ProductCode: DTQ Decision Date To: 02/26/2017
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sarns 7000 monitor module 3M HEALTH CARE, SARNS K801097 05/20/1980
sarnes help 3M HEALTH CARE, SARNS K772001 11/02/1977
s3 cardioplegia control module version 2.0 MEDICAL DEVICE CONSULTANTS, INC. K002116 08/09/2000
quantumn centrifugal drive- high pressure, quantum centrifugal drive- medium pressure Spectrum Medical Ltd K192838 04/13/2020
quantum smart occluder lh (left-hand), quantum smart occluder lh (right-hand) Spectrum Medical Ltd K190282 05/24/2019
quantum pump console Spectrum Medical Ltd K173834 05/25/2018
polystan heart lung machine sys ADVOCACY INTERNATIONAL, LTD. K813034 11/27/1981
performer cbp system RAND S.R.L. K070213 03/21/2007
onguard 1000, catalog #043611-000 & 043611-001 COBE LABORATORIES, INC. K870976 05/06/1987
modification to: stockert s5 system SORIN GROUP DEUTSCHLAND GMBH K071318 07/06/2007
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