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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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510(K)
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cd horizon spinal system MEDTRONIC SOFAMOR DANEK, INC. k000641 12/22/2000
aiw water system for hemodialysis AMERICAN INDUSTRIAL WATER k001282 12/15/2000
acti-flex fluid delivery system or acti-flex f d s R-GROUP INTL. k001233 12/13/2000
orthomatrix, inc. cerclage system ORTHOMATRIX, INC. k001254 12/13/2000
schaefer water center hemodialysis water purification system, model hwps-100 SCHAEFER WATER CENTERS k000249 12/11/2000
ebt ultrafast ct scanner system; c-100, c-150, c-150lxp or c-150xp scanner systems; electron beam scanner system; electr IMATRON, INC. k001550 12/11/2000
auto suture premium plus ceea disposable stapler UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k001895 12/08/2000
tcm400 RADIOMETER MEDICAL A/S k001866 12/07/2000
modification to intralase 600c laser keratome INTRALASE CORP. k001211 12/04/2000
infusomat p B. BRAUN MEDICAL, INC. k003029 12/04/2000

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