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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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liberty blood glucose monitoring system POLYMEDICA PHARMACEUTICALS, U.S.A., INC.] k014167 02/19/2002
au6 (technos/technos mp) ultrasound imaging system (addition of 3d imaging mode and musculoskeletal indication) BIOSOUND ESAOTE, INC. k014168 04/25/2002
water purification components for hemodialysis BOB J. JOHNSON & ASSOC., INC k014169 02/06/2002
staurenghi wide field scanning laser lens OCULAR INSTRUMENTS, INC. k014170 03/04/2002
advance unicondylar knee system WRIGHT MEDICAL TECHNOLOGY, INC. k014171 03/15/2002
nelson electrosurgical unit, model gn640 AESCULAP, INC. k014172 03/19/2002
synchron systems salicylate reagent and calibrator BECKMAN COULTER, INC. k014173 02/15/2002
harvey pv dry sterilizer, model # st127325; st127320; st127320-33 BARNSTEAD/THERMOLYNE CORP. k014174 02/22/2002
sulzer dental ceramic system-hexlock SULZER DENTAL, INC. k014175 03/20/2002
demetron lc KERR CORP. k014179 02/04/2002

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