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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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dimension urine ecstasy screen flex reagent cartridge, model df 109 DADE BEHRING, INC. k053337 05/19/2006
inspectra tissue spectrometer system, model 325 HUTCHINSON TECHNOLOGY, INC. k053618 02/08/2006
pioneer tc8080, companion iii VIASYS NEURO CARE k053648 01/24/2006
healthstats bpro ambulatory blood pressure monitoring system HEALTHSTATS INTERNATIONAL PTE. LTD. k060315 04/07/2006
nellcor oximax n-600x pulse oximeter NELLCOR PURITAN BENNETT, INC. k060576 08/14/2006
zimmer dental one piece tapered abutment, models tac1, tacw1, ta5c1 ZIMMER DENTAL INC. k060880 05/17/2006
dbx-h hemostatic demineralized bone matrix putty ORTHOCON, INC. k061131 02/08/2007
endopath endocutter 60 endoscopic linear cutter, models ec60, sc60 and long60 and endopath & proximate linear cutters ETHICON ENDO-SURGERY, INC. k061156 07/03/2006
system 83 plus miniflex washer-disinfector CUSTOM ULTRASONICS k061430 01/12/2007
palomar lux1540 handpiece PALOMAR MEDICAL PRODUCTS, INC. k061652 02/27/2007

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