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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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vigilance cco/cedv & vigilance cco/svo2/cedv monitors BAXTER HEALTHCARE CORP. k000664 09/20/2000
galeo hydro and galeo hydro j-tip BIOTRONIK, INC. k001736 08/02/2000
distal volar radius fracture repair system HAND INNOVATIONS, INC. k002775 12/05/2000
regain desktop SRS MEDICAL SYSTEMS, INC. k003127 01/04/2001
sansibar cpap system PRYM MEDICAL LTD. k000888 08/15/2000
baylis pain management probe/pmp-20-145 and baylis pain management connector cable/pmx-bay-bay BAYLIS MEDICAL CO., INC. k002389 10/23/2000
disposable pressure monitor ENGINEERED MEDICAL SYSTEMS k003497 11/30/2000
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
i-stat portable clinical analyzer, model 300 I-STAT CORP. k001387 10/05/2000

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