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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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chemelia enzyme immunoassay for (tsh) Boots-Celltech Diagnostics, Inc. k873625 10/20/1987
blackstone spinal fixation system 4.5mm multi-axial screw Blackstone Medical, Inc. k020674 04/03/2002
bird tbird vela ventilator Bird Products Corp. k032451 03/17/2004
ventilator stand Bird Products Corp. k914485 10/25/1991
webster cs catheter with ez steer technology, webster cs catheter with ez steer technology and auto id model: d-1263-04, Biosense Webster, Inc. k101345 06/22/2010
paxial Biophysic Medical, Inc. k853116 10/31/1985
soft tissue screw and washer Biomet, Inc. k012572 12/03/2001
ringloc + hybrid acetabular system Biomet, Inc. k093235 04/30/2010
fracture/reconstruction system (traumaone) Biomet Microfixation, Inc. k081067 05/09/2008
comprehensive convertible glenoid Biomet Manufacturing, Inc. k130390 10/09/2013

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