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U.S. Department of Health and Human Services

510(K) Premarket Notification
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bardex latex-free temperature-sensing foley catheter (uncoated); bardex lubri-sil temperature-sensing foley catheter (lu C.R. Bard, Inc. k003289 01/05/2001
ball electrodes National Wire & Stamping, Inc. k861595 06/19/1986
bag-to-ventilator selector valve Ohio Medical Products k841274 04/13/1984
axiom orthopaedics shoulder resurfacing system Axiom Orthopaedics, Inc. k061862 08/28/2006
autopulse, model 100 Revivant Corp. k011046 10/25/2001
augustine medical bair huuger, model 750 total temperature management system-(model 750 warming unit, bair hugger blank Augustine Medical, Inc. k001149 09/06/2000
audio technologies s:r.1 Audio Technologies S.R.L. k001142 06/23/2000
atomizer, furnace model hga-400 The Perkin-Elmer Corp. k790111 04/04/1979
astra tech implants - dental system Astra Tech, Inc. k002513 01/04/2001
ascent dental cleanser CAO Group, Inc. k070070 05/25/2007

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