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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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modification to onyx, finger clip pulse oximeter, model 9500 NONIN MEDICAL, INC. k001085 05/01/2000
inplant orthodontic anchor system NOBEL BIOCARE UAS INC k000643 09/07/2000
infusion iv set NIRVI INTL. USA k001879 11/20/2001
nipro insulin syringe NIPRO MEDICAL CORP. k000144 02/11/2000
nikopad electrosurgical grounding pad, model 4777m NIKOMED U.S.A., INC. k000079 02/04/2000
cns-9300 series central station NIHON KOHDEN AMERICA, INC. k001433 11/07/2000
nichols advantage thyroglob NICHOLS INSTITUTE DIAGNOSTICS k002888 10/20/2000
cardioset (hardware), model ho4; cardioset scl (software), model v3.01 NEXT MILLENNIUM SOFTWARE SOLUTIONS, INC. k001091 08/10/2000
neocontrol pelvic floor therapy system NEOTONUS, INC. k001903 08/29/2000
pns magnetic stimulator system NEOTONUS, INC. k002889 04/06/2001

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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