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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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510(K)
Number
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Decision
Date
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heartrak smart at/heartrak smart2 UNIVERSAL MEDICAL, INC. k033451 02/05/2004
aegis pit & fissure sealant with acp HARRY J. BOSWORTH CO. k033751 02/05/2004
volar radius plate with angular stability I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH k033756 02/06/2004
hermes bond 3M ESPE AG DENTAL PRODUCTS k033974 02/06/2004
ensphere tempo jetstream workspace cardiology module ADAC LABORATORIES k040142 02/06/2004
cstat, models 09-0014-01 and 09-0014-02 VASCULAR CONTROL SYSTEMS, INC k032125 02/09/2004
titanium mesh system ENCORE MEDICAL, L.P. k032371 02/12/2004
liaison n-tact pth DIASORIN, INC. k033426 02/12/2004
iq guide wire BOSTON SCIENTIFIC CORP. k040140 02/12/2004
viceroy inflation device MERIT MEDICAL SYSTEMS, INC. k040138 02/13/2004

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