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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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510(K)
Number
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Decision
Date
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alpha y-recipient set Alpha Therapeutic Corp. k833294 12/27/1983
alta dressing frame Alta Medical Products, Inc. k926380 08/06/1993
altus spine pedicle screw system, altus spine mis pedicle screw system, valencia pedicle screw system, valencia mis pedicle screw system Altus Partners, LLC k151648 10/16/2015
ambio remote health monitoring system Arrayent Health, LLC D/B/A Ambio Health k130676 07/08/2013
amizyme-andna test kit Amico Lab, Inc. k842533 09/20/1984
angioplus-s Oec-Diasonics, Inc. k843972 01/03/1985
angioskip Siemens Corp. k781991 12/07/1978
argelite 76sf+ dental alloy Argen Precious Metals, Inc. k892910 06/14/1989
aristotle 18 guidewire, 200cm, soft profile ; aristotle 18 guidewire, 200cm, standard profile ; aristotle 18 guidewire, 200cm, support profile Scientia Vascular, LLC k183608 03/22/2019
ascension humeral resurfacing arthoplasty (hra) system tps/ha Ascension Orthopedics, Inc. k071064 06/22/2007

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