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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
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dermmatrix surgical mesh CARBON MEDICAL TECHNOLOGIES, INC. k021160 06/12/2002
tso3 ozone chemical indicator TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC k021161 08/27/2003
amax density coagulation analyzer, amax denstiny coagulation analyzer-eu, amax destiny coagulation analyzer-refurbished SIGMA DIAGNOSTICS, INC. k021162 08/30/2002
octeia 25-hydroxy vitamin d IMMUNODIAGNOSTIC SYSTEMS LTD. k021163 05/10/2002
macropore os trauma MACROPORE BIOSURGERY, INC. k021164 07/01/2002
medpor plus orbital volume replacement impant POREX SURGICAL, INC. k021357 08/05/2002
embryo biopsy medium IRVINE SCIENTIFIC SALES CO., INC. k021358 07/05/2002
digi-pro tens model wl-2203 and wl-2205 WELL-LIFE HEALTHCARE, INC. k021359 04/30/2002
scintillating fiber dosimeter (sfd), model mt-sfd-1000 MED-TEC,INC. k021360 06/10/2003
lifeport, kidney perfusion transporter (ktr) ORGAN RECOVERY SYSTEMS, INC. k021362 07/31/2003

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