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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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z-net DEMITE LIMITED k001003 12/10/2001
owl radiofrequency system, model urf-2a, and associate radiofrequency lesion probes LESLIE W. ORGAN k010202 10/31/2001
biopatch antimicrobial dressing INTEGRA LIFESCIENCES CORP. k003229 10/26/2001
sterilmed intermittent compression system, garment models 400 series STERILMED, INC. k003857 10/18/2001
end expiratory filter, model rt020 FISHER & PAYKEL HEALTHCARE, LTD. k002839 10/04/2001
solid state x-ray imaging devices CARES BUILT, INC. k003238 10/01/2001
omnicare dental implant system OMNICARE DENTAL IMPLANT CENTER k000035 09/28/2001
nsi hexed and non-hexed implant system NSI k003620 09/19/2001
colormate tlc bilitest system CHROMATICS COLOR SCIENCES INTL., INC. k001687 09/13/2001
aquanet, model ec 2000 PRIME PACIFIC HEALTH INNOVATIONS CORPORATION k000031 09/10/2001

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