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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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knight endoscopic spine system (kess) RICHARD WOLF MEDICAL INSTRUMENTS CORP. k000046 03/30/2000
vacuflow+ blood collection set, model 52221/3/5; vacuflow+ with holder blood collection set, model 82021/3/5 with holder MEDPRO TECHNOLOGIES, INC. k000369 03/30/2000
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
spiro pro ERICH JAEGER GMBH k000648 03/29/2000
automated non-invasive blood pressure monitor, model bpm-100 VSM MEDTECH LTD. k994423 03/28/2000
impact.wf mobile waveform receiving system GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN k994430 03/28/2000
gel mark biopsy site marker, models mkooo1, mk0004, mk0007 SENORX, INC. k000060 03/27/2000
nova cordless curing light NOVA/DA VINCI SYSTEMS, INC. k000393 03/27/2000
aesculap bone wax AESCULAP, INC. k000021 03/24/2000
nupro prophylaxis paste with fluoride and triclosan DENTSPLY INTL. k000169 03/24/2000

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