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U.S. Department of Health and Human Services

510(K) Premarket Notification
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21 to 30 of 493 Results
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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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laser mechanisms laser scanning system LASER MECHANISMS, INC. k010113 04/12/2001
candela long pulse nd:yag CANDELA CORP. k010104 04/11/2001
echoseed/iodine-125 seeds, model 6733 MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING k010821 04/11/2001
avon patello-femoral joint prosthesis HOWMEDICA OSTEONICS CORP. k010100 04/06/2001
periform perineometric probe, model 8300 NEEN DESIGN LTD. k002617 04/05/2001
white knight masks (21 models, various colors with and without face shields) WHITE KNIGHT HEALTHCARE, INC. k001892 04/03/2001
powder-free nitrile examination gloves, white SHEN WEI (USA), INC. k010110 04/03/2001
white knight masks, blue, pink, yellow, white masks (13 models) WHITE KNIGHT HEALTHCARE, INC. k001893 04/02/2001
xltek evoked potential headbox, model real patient ep-8-rp (proposed) EXCEL TECH. LTD. k010092 04/02/2001
bipolar coagulation system ENABLE MEDICAL CORP. k010112 04/02/2001

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