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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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powerheart aed g3, model 9390e, powerheart aed g3 automatic, model 9390a CARDIAC SCIENCE CORPORATION k091943 09/10/2009
prebent plating with virtual surgical planning BIOMET MICROFIXATION k131674 08/08/2013
precision 500d r&f x-ray system GE HEALTHCARE k081091 06/11/2008
premium slow speed; 20k air motor, heads, contra-angles, straight nosecones SABLE INDUSTRIES, INC. k083101 02/23/2009
primaconnex cad/cam abutment system LIFECORE BIOMEDICAL, INC. k072241 11/09/2007
prime-dent chemical cure composite restorative material PRIME DENTAL MANUFACTURING, INC. k994224 01/31/2000
profemur lx hip stem WRIGHT MEDICAL TECHNOLOGY, INC. k053588 01/13/2006
profemur lx revision 5/8 coated hip stem WRIGHT MEDICAL TECHNOLOGY, INC. k080663 04/08/2008
prosoft (phemfilcon) soft (hydrophilic) contact lens WESLEY JESSEN CORP. k994335 03/20/2000
prospore2 self-contained biological indicator RAVEN BIOLOGICAL LABORATORIES, INC. k994381 03/30/2001

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