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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
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Decision
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fukuda denshi dynascope model ds-5700 FUKUDA DENSHI USA, INC. k020084 02/06/2002
sigma diagnostics accuclot la control SIGMA DIAGNOSTICS, INC. k020109 02/06/2002
orthosis helmet molding PRECISION PROSTHETICS & ORTHOTICS, INC. k013700 02/05/2002
erecaid classic system; erecaid esteem manual system; erecaid esteem battery system ENDOCARE, INC. k020082 02/05/2002
veraviewepocs, model ve J. MORITA USA, INC. k013955 02/04/2002
demetron lc KERR CORP. k014179 02/04/2002
bd vacutainer safety coagulation tube BECTON DICKINSON & CO. k013971 02/01/2002
machnet bilateral open breast coil. catalog # mics-gsxx MACHNET BV k013985 02/01/2002
biotech b990k vivi wheelchair TAIWAN ARMADA ENTERPRISE CO., LTD. k014198 02/01/2002
phoenix eletrolyte calibration set for the roche cobas ise module PHOENIX DIAGNOSTICS, INC. k020129 02/01/2002

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