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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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endorez ULTRADENT PRODUCTS, INC. k042756 10/26/2004
needle incapacitator (needle guard) PDMP, INC. k042907 12/22/2004
randox phencyclidine assay RANDOX LABORATORIES, LTD. k043071 01/27/2005
dragon heart i.v. set DRAGON HEART MEDICAL DEVICES CO., LTD. k043235 03/08/2005
reprocessed ep technologies electrophysiology catheters ALLIANCE MEDICAL CORP. k043393 03/23/2005
medela dominant 35 c/i secretion and surgical aspirator MEDELA AG k043544 01/07/2005
p-stim system NEUROSCIENCE THERAPY CORP. k050123 03/30/2006
aequalis reversed shoulder prosthesis TORNIER k050316 03/16/2005
t-sling HERNIAMESH S.R.L. k050516 02/03/2006
altaire HITACHI MEDICAL SYSTEMS AMERICA, INC. k050602 04/07/2005

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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