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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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axillary access arterial cannula EDWARDS LIFESCIENCES, LLC. k002578 04/11/2002
centurion 2000 central station arrhythmia patient monitoring system INVIVO RESEARCH, INC. k002604 02/07/2002
gentle colonics irrigation system GENTLE COLONICS, INC. k002102 02/06/2002
omnicare dental implant system OMNICARE DENTAL IMPLANT CENTER k000035 09/28/2001
aquanet, model ec 2000 PRIME PACIFIC HEALTH INNOVATIONS CORPORATION k000031 09/10/2001
jms a.v. fistula needle set accordion type JMS CO., LTD. k002352 09/06/2001
vulcan tac probes, model 911xxx ORATEC INTERVENTIONS, INC. k003198 08/29/2001
sios-interface for auto light projector, sios-interface for 3 ccd endocam, sios-interface for laparo co2 insufflator RICHARD WOLF MEDICAL INSTRUMENTS CORP. k002328 08/27/2001
aems v, ems-1000, model ts-140500 and aems vi, ems-1000 plus, model ts-140600 APEX MEDICAL CORP. k002339 08/24/2001
disposable hypodermic needle electrode, model 9013s0421,9013s0431,9013s0441,9013s0451,9013s0461,1013s0421,103s0431 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S k002992 08/15/2001

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