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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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Applicant
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510(K)
Number
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Decision
Date
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ca 125 ii calcheck ROCHE DIAGNOSTICS CORP. k003967 01/12/2001
elecsys ca 125 ii calset ROCHE DIAGNOSTICS CORP. k003969 01/12/2001
accu-chek compact system, accu-chek compact test strips, accu-chek compact compact controls ROCHE DIAGNOSTICS CORP. k004010 04/26/2001
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
hysteroscope operating sheath and insert, model 8988.031/.041/.231/.241 RICHARD WOLF MEDICAL INSTRUMENTS CORP. k000673 05/26/2000
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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