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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Applicant
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510(K)
Number
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Decision
Date
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calcium sulfate pellets HOWMEDICA OSTEONICS CORP. k001559 06/20/2000
cambridge heart micro-v alternans sensor, model 20327-002 CAMBRIDGE HEART, INC. k002230 08/18/2000
candela sptl-1b pulsed dye laser CANDELA CORP. k001093 09/19/2000
cannulation tourniquet set, 2 tube or 5 tube CALIFORNIA MEDICAL LABORATORIES, INC. k000830 09/07/2000
capiox sx hardshell reservoir with x-coating TERUMO CARDIOVASCULAR SYSTEMS CORP. k002238 08/22/2000
cardioset (hardware), model ho4; cardioset scl (software), model v3.01 NEXT MILLENNIUM SOFTWARE SOLUTIONS, INC. k001091 08/10/2000
cardiovascular array W.L. GORE & ASSOCIATES,INC k013810 11/27/2001
cardiovations portable video system ETHICON, INC. k032339 08/08/2003
carto xp and qwikmap ep navigation system BIOSENSE WEBSTER, INC. k020863 01/09/2003
castellni air powered handpieces syringes: three steril, multisteril turbins: cleanair, cleanlight micromotors: implanto CASTELLINI S.P.A. k000834 12/14/2000

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