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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
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freezor xtra surgical cardiac cryoablation device and cct.2 cardiac cardiac cryoablation cryoconsole CRYOCATH TECHNOLOGIES, INC. k030303 04/29/2003
1,3 & 4 way sterile dis. plastic pkg. CUSTOM MEDICAL DEVICES INTL., INC. k800862 05/30/1980
vimplant CYBERMED, INC. k053155 11/23/2005
flow med 160 D.R.O. MEDICAL, INC. k801179 05/30/1980
stratus cs acute care mb isoenzyme of creatine kinase (ckmb) test pak; stratus cs acute care ckmb testpak. DADE BEHRING, INC. k051650 09/08/2005
criterion ii pacing system monitors DART MEDICAL EQUIPMENT k800286 03/12/1980
cardiosave hybrid and rescue intra-aortic balloon pump, cardiosave li-ion battery transport and storage case Datascope Corp. k163542 01/31/2017
whirlpool bath model 2270 DAZEY PRODUCTS CO. k771967 10/28/1977
epy-50 DDC TECHNOLOGIES, INC. k020513 05/16/2002
ultrafill- ultrabound DEMETRON RESEARCH CORP. k781345 08/31/1978

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