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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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pedi-padz radiolucent multi-function pediatric electrodes, model 8900-1005 BIO-DETEK, INC. k040256 04/09/2004
pascal dynamic contour tonometer SMT SWISS MICROTECHNOLOGY AG k032967 11/14/2003
palomar slp 2000 PALOMAR MEDICAL TECHNOLOGIES, INC. k994225 05/18/2000
pacendo sodium hyprochlorite PAC-DENT INTERNATIONAL, INC. k151852 11/10/2015
ovum pick-up needles with aq coating, aspiration needles with aq coating COOK UROLOGICAL, INC. k994417 03/01/2000
orthoralix 9200, orthoralix 9200 plus, orthoralix 9200 ceph, orthoralix 9200 plus ceph DENTSPLY INTL. k994285 03/14/2000
orthopro steinman pins and kirschner wires ORTHOPRO LLC k070555 07/13/2007
ortho development balanced knee system ORTHO DEVELOPMENT CORP. k994370 03/24/2000
orion digital imaging system INFIMED, INC. k012490 02/12/2002
ora-50 electrothermal system and accessories ORATEC INTERVENTIONS, INC. k994333 01/18/2000

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