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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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palceram 53 AUREX SA (PTY) LTD. k001479 06/21/2000
instant-view marijuana (thc) urine dip strip test ALFA SCIENTIFIC DESIGNS, INC. k994410 06/21/2000
instant-view marijuana urine cassette test ALFA SCIENTIFIC DESIGNS, INC. k994405 06/02/2000
reach femoral component BIOMET, INC. k000760 05/23/2000
glovetex, latex examination gloves, powdered non-sterile.(protein content labeling) PT. WRP BUANA MULTICORPORA k994426 05/23/2000
connect data management system ABBOTT DIABETES CARE INC. k994433 05/05/2000
active electrode monitoring system ELECTROSCOPE, INC. k000480 05/02/2000
cedia dau amphassure assay MICROGENICS CORP. k994380 05/02/2000
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
automated non-invasive blood pressure monitor, model bpm-100 VSM MEDTECH LTD. k994423 03/28/2000

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