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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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ohmeda inovent delivery system OHMEDA MEDICAL den000001 01/11/2000
reichert ct200 contact tonometer REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC. k000288 03/23/2000
urine methadone (meth) screen flex reagent cartridge, catalog no. df 93a DADE BEHRING, INC. k000466 04/05/2000
parset primary set with check valve, model a10002e RD MEDICAL MFG., INC. k001102 04/20/2000
galeo hydro and galeo hydro j-tip BIOTRONIK, INC. k001736 08/02/2000
stockert compact system version 2.0 STOECKERT INSTRUMENTE k002118 08/09/2000
sansibar cpap system PRYM MEDICAL LTD. k000888 08/15/2000
midas touch latex examination gloves-powdered INDUSTRIAL CLOTHINGS, LTD. k000141 09/13/2000
vigilance cco/cedv & vigilance cco/svo2/cedv monitors BAXTER HEALTHCARE CORP. k000664 09/20/2000
i-stat portable clinical analyzer, model 300 I-STAT CORP. k001387 10/05/2000

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