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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)
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Decision
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modification to variant ii: hemoglobin a1c program, beta-thalassemia short program and total ghb program BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI k063643 12/27/2006
heartstart mrx, models m3535a or m3536a PHILIPS MEDICAL SYSTEMS k063375 01/11/2007
sock it! oral pain gel MERLIN GROUP DBA MCMERLIN DENTAL COMPANY k063148 01/17/2007
architect shbg reagent kit, architect shbg calibrator kit, and architect shbg control kit with models, 8k26-25, 8k26-01 BIOKIT S.A. k060818 01/23/2007
lifepak 12 defibrillator/monitor MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. k063510 01/26/2007
synthes oracle spacer SYNTHES SPINE CO.LP k062933 01/31/2007
powder free vinyl patient examination glove HONG DI PLASTIC PRODUCTS CO, LTD. k070187 02/13/2007
sidestream plus RESPIRONICS LTD. k062689 02/16/2007
advacoat sinus gel and stent CARBYLAN BIOSURGERY k070496 03/15/2007
axsym anti-ccp reagent, standard calibrator and control kits, models 3l91-20, 3l91-01 and 3l91-10 AXIS-SHIELD DIAGNOSTICS, LTD. k063347 03/20/2007

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