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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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marks reference phantom, measure reference phantom THE PHANTOM LABORATORY, INC. k002840 11/17/2000
rosetta-lt/rosetta-rx GENERAL DEVICES k002089 11/21/2000
k-defib/pace, model kdp-60a KATECHO, INC. k002806 11/21/2000
nipro safetouch safety fistula needle NIPRO MEDICAL CORP. k002813 11/21/2000
transonic hemodialysis flow reverser, model b flowrev TRANSONIC SYSTEMS, INC. k002816 11/22/2000
neuro scan medical ststems, model medicor 8 NEUROSOFT, INC. k001692 11/24/2000
salumedica nerve cuff SALUMEDICA, L.L.C. k002098 11/24/2000
delta 32 and delta 32 tact INSTRUMENTARIUM IMAGING, INC. k002472 11/29/2000
nirtrile patient examination glove (blue color) powdered, non sterile SIAM SEMPERMED CORP. LTD. k002818 11/29/2000
nitrile patient examination glove (green color) powdered, non sterile SIAM SEMPERMED CORP. LTD. k002819 11/29/2000

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