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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
Date
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emit ii plus monoclonal cocaine metabolite assay DADE BEHRING, INC. k020441 03/28/2002
hd/hdt, (polymacon) soft contact lens for daily wear (clear and tinted, fully cast-molded lens) POLY VUE TECHNOLGIES, INC. k020608 05/16/2002
surgassist system straight linear cutter digital loading unit, 55mm, 30mm with blue and green reload cartridges POWER MEDICAL INTERVENTIONS, INC. k020719 05/10/2002
renut multiplus mullti-purpose solution BAUSCH & LOMB INCORPORATED k020802 05/31/2002
bowti anterior buttress staple system DEPUYACROMED k021039 12/11/2002
powdered latex surgiacal gloves, steerile with expiration date labeling claim WRP ASIA PACIFIC SDN. BHD. k021159 07/03/2002
magnetom trio quadrature tx/rx head coil USA INSTRUMENTS, INC. k021330 07/25/2002
rapido guiding catheter, 6f model# 6776; rapido guiding catheter, 8f model# 6775, 6777, 6778, 6779, 6780, 6781, 6782, GUIDANT CORP. k021455 08/02/2002
hispeed dual GE MEDICAL SYSTEMS, INC. k021491 05/22/2002
ebi dynafix diaphyseal correction system EBI, L.P. k021695 06/20/2002

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