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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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tri-plex adapter The Medical Device Group, Inc. k010401 10/30/2002
sleep pat 200 device Itamar Medical (C.M.) 1997 , Ltd. k010156 06/19/2002
klockner dental implants, models sk, nk, ik, s3, and s4 Soadco, S.L. k010132 06/04/2002
cook vascular peel-away hemostasis valve Cook Vascular, Inc. k010128 04/25/2002
bi-directional doppler volume flowmeter, model dvm-4300 & 4300t Koven Technology, Inc. k010452 02/12/2002
microlight 830 laser system Microlight Corporation OF America k010175 02/06/2002
hedrocel vertebral body replacement, model xx-yyy-zzzz Implex Corp. k010378 01/28/2002
shapeable doppler flow probe Cook Vascular, Inc. k002958 12/18/2001
sondrex p.a.l. system Ohmeda Medical k010388 12/11/2001
imagyn isosleeve / isostar needle system Imagyn Medical Technologies, Inc. k010166 12/03/2001

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