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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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model 3300e/er monoplace hyperbaric oxygen chamber SECHRIST INDUSTRIES, INC. k052713 10/28/2005
infrared thermometer, fdir-v1 FAMIDOC TECHNOLOGY CO., LTD k052849 10/26/2005
wireless physiologic monitoring system EDWARDS LIFESCIENCES, LLC. k053016 12/30/2005
vimplant CYBERMED, INC. k053155 11/23/2005
alphasphere orbital implant HYDRON PTY LIMITED k053298 05/09/2006
gen-probe aptima assay for chlamydia trachomatis, model 1088 GEN-PROBE, INC. k053446 07/25/2006
endosseous dental implant system NORTHERN IMPLANTS, LLC k053478 04/05/2006
inspectra tissue spectrometer system, model 325 HUTCHINSON TECHNOLOGY, INC. k053618 02/08/2006
peripheral cutting balloon BOSTON SCIENTIFIC CORP. k040155 07/01/2004
kerato analyzer (eka) KONAN MEDICAL, INC. k040373 03/19/2004

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