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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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jb-70 intraoral x-ray system, models 30-a0001/a0002 PROGENY, INC. k020070 02/01/2002
mityvac PRISM ENTERPRISES, INC. k011532 07/30/2001
mityvac merlin, model 10027 PRISM ENTERPRISES, INC. k020447 04/12/2002
lifesign met, status stik met, accusign stik met, accustik met, accusign met, status ds met PRINCETON BIOMEDITECH CORP. k014192 05/23/2002
lifesign doa 4 (thc/opi/coc/met) PRINCETON BIOMEDITECH CORP. k014193 05/23/2002
status hcg serum/urine PRINCETON BIOMEDITECH CORP. k020439 05/23/2002
medpor plus surgical implant biomaterial POREX SURGICAL, INC. k012350 03/14/2002
hd/hdt, pv/pvt (polymacon) soft contact lens for daily wear (clear and tinted, fully cast-molded lens) POLY VUE TECHNOLGIES, INC. k013220 11/20/2001
babycom PMG MEDICA LTD. k013547 02/20/2002
phoenix electrolyte calibration set for the medical easylyte calcium analyzer PHOENIX DIAGNOSTICS, INC. k012987 11/07/2001

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