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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
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glucose diagnostic reagent CONNECTICUT DIAGNOSTICS, LTD. k801897 10/10/1980
glocyte automated cell counter system Advanced Instruments, Inc. k152776 05/27/2016
gexfix external fixation Gexfix International Corp. k160972 12/28/2016
generator, pulse, bipolar 3608 CARDIAC PACEMAKERS, INC. k770881 06/20/1977
geko FIRSTKIND LIMITED k133638 08/21/2014
ge echopac GENERAL ELECTRIC CO. k072952 11/16/2007
gdc-10 360 degree coil sr; gdc-10 360 degree soft coil sr; gdc-18 360 degree coil BOSTON SCIENTIFIC CORP. k042539 10/19/2004
gdc stretch resistant detachable coil BOSTON SCIENTIFIC, TARGET k030475 03/14/2003
gamma counter LKB INSTRUMENTS, INC. k780344 04/12/1978
gambro pump console csl GAMBRO, INC. k822068 08/24/1982

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