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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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elecsys b-crosslaps calcheck ROCHE DIAGNOSTICS CORP. k000042 03/17/2000
elecsys insulin calset ROCHE DIAGNOSTICS CORP. k001906 07/13/2000
camit diabetes management software ROCHE DIAGNOSTICS CORP. k001907 09/05/2000
tina-quant rheumatoid factors ii test system ROCHE DIAGNOSTICS CORP. k002609 09/05/2000
knight endoscopic spine system (kess) RICHARD WOLF MEDICAL INSTRUMENTS CORP. k000046 03/30/2000
transanal endoscopic microsurgery (tem) combination system and instrument set, instrument set for the transanal endoscop RICHARD WOLF MEDICAL INSTRUMENTS CORP. k000180 03/02/2001
urethrotome 8667.xxx and 8670.xxx RICHARD WOLF MEDICAL INSTRUMENTS CORP. k000905 05/12/2000
rhinoscan model sre2000/ sre2100 with acoustic rhinometry module RHINOMETRICS A/S k000406 04/17/2000
transpak (vitreoretinal infusion pak), models 90000, 90001 RETINALABS.COM k000416 05/08/2000
pdt dosecalculator, model 80000 RETINALABS.COM k000418 10/24/2000

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