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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)
Number
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Decision
Date
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s/5 compact anesthesia monitor with s-00a05, s-00a06. l-00a07, l00a08 DATEX-OHMEDA, INC. k002478 10/05/2000
paragon cze 2000 capillary electrophoresis system and buffer-100 BECKMAN COULTER, INC. k002799 10/05/2000
rapid exchange tapertome BOSTON SCIENTIFIC CORP. k002802 10/05/2000
n protein standard sl DADE BEHRING, INC. k002804 10/05/2000
speedlink transverse connector SPINAL CONCEPTS, INC. k002082 10/06/2000
bard memotherm covered esophageal stent, model multiple C.R. BARD, INC. k002094 10/06/2000
q-lux plasma 100 light cure unit ROLENCE ENTERPRISE CO. LTD. k001719 10/10/2000
model 4815 adapter PACE MEDICAL k002496 10/10/2000
model 4810 analyzer output adapter PACE MEDICAL k002497 10/10/2000
narkomat, model 2000 HEYER AMERICA, INC. k000995 10/11/2000

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