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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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reliefband nst device, model wb-2l, wb-6l, wb-rl WOODSIDE BIOMEDICAL, INC. k994387 03/16/2000
xe check STRECK LABORATORIES, INC. k994388 01/14/2000
cobe hvr 2200 hardshell venous reservoir, filtered COBE CARDIOVASCULAR, INC. k994389 03/27/2000
gambro polyflux 17r, capillary dialyzer/ filter GAMBRO HEALTHCARE k994390 10/26/2000
aequalis shoulder fracture system TORNIER k994392 03/10/2000
aequalis universal shoulder glenoid TORNIER k994393 06/22/2000
instant-view amphetamine urine cassette test ALFA SCIENTIFIC DESIGNS, INC. k994395 08/07/2000
instant-view cocaine (benzylecgonine) urine cassette test ALFA SCIENTIFIC DESIGNS, INC. k994398 07/27/2000
instant-view amphetamine urine dip strip test ALFA SCIENTIFIC DESIGNS, INC. k994399 08/04/2000
instant-view methamphetamine urine cassette test ALFA SCIENTIFIC DESIGNS, INC. k994400 08/04/2000

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