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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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airis elite rapid body coil HITACHI MEDICAL SYSTEMS AMERICA, INC. k050307 02/28/2005
airlife nasal continuous positive airway pressure (ncpap) sytem driver Cardinal Health k051226 11/17/2005
airnergy+stream NATURAL ENERGY SOLUTIONS AG k052492 09/05/2006
alden classic (polymacon) multifocal (spherical and toric), alden classic 55 (methafilcon a) multifocal (spherical ALDEN OPTICAL LABS., INC. k052703 11/10/2005
aleutian spacer system K2M, LLC k051454 07/27/2005
altus medical optional infrared handpiece ALTUS MEDICAL, INC. k033768 02/17/2004
aluma skin renewal system LUMENIS, INC. k051214 10/24/2005
ambit push & play ambulatory infusion pump SORENSON MEDICAL, INC. k052221 12/08/2005
ambu pediatric multi-function defibrillation electrode AMBU, INC. k032421 02/27/2004
ameriwater solution mix and distribution system for hemodialysis AMERIWATER k051031 01/06/2006

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