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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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cd horizon eclipse MEDTRONIC SOFAMOR DANEK, INC. k001066 06/22/2000
behring coagulation timer analyzer (bct) DADE BEHRING, INC. k001064 06/21/2000
seragard injection patch PLATINUM SERVICES, INC. k001240 06/21/2000
dentalmatic ti prosthesis and dentalmatic ti-a prosthetic DENTALMATIC TECHNOLOGIES, INC. k001269 06/21/2000
temporary gingival cuff and impression post and implant analog SULZER CALCITEK, INC. k001786 06/21/2000
3d-mspect THE REAGENTS OF THE UNIVERSITY OF MICHIGAN k001026 06/20/2000
dade behring coagulation analyzer (bct) DADE BEHRING, INC. k001067 06/20/2000
pc coated fluoroplastic vent tubes GYRUS ENT L.L.C. k000801 06/19/2000
contempro-mist CONTEMPORARY PRODUCTS, INC. k000543 06/16/2000
absolute hcg pregnancy test MIZUHO USA, INC. k000844 06/16/2000

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