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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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osi medical dolphin stand-alone pulse oximeter, model 2100 and digital dolphin optical sensor, clip-on finger probe, mod OSI MEDICAL, INC. k002036 04/17/2001
y-tzp powder and procera allzirkon PROCERA SANDVIK, INC. k010630 04/17/2001
modification to synthes (usa) polypin SYNTHES (USA) k003527 04/09/2001
preamp cable, model b400-1011pa BETA BIOMED SERVICES, INC. k003542 04/06/2001
ultravue/p 2000t, ultravue/c 2000t (hioxifilcon b) soft (multifocal toric) daily wear contact lens (clear & blue visibil OPTI-CENTRE LABORATORIES k010256 03/26/2001
ppcid- pneumatic peripheral circulation improvement (footrest) device AHAVA STEIN k000655 03/26/2001
components for cardiovascular procedure kit - heat exchanger coils OLSON MEDICAL SALES, INC. k000977 03/23/2001
blastassist system MEDICULT A/S k003156 03/22/2001
synvitro flush MEDICULT A/S k003163 03/22/2001
niroyal biliary premounted stent system BOSTON SCIENTIFIC CORP. k003929 03/22/2001

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