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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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smith & nephew model 660hd image management system SMITH & NEPHEW, INC. k060777 04/13/2006
synergy hip system SMITH & NEPHEW, INC. k061066 07/14/2006
peri-loc periarticular locked plating system for the upper extremity SMITH & NEPHEW, INC. k061352 06/08/2006
peri-loc periarticular locked plating system SMITH & NEPHEW, INC. k062216 09/15/2006
versajet hydrosurgery system and handpiece SMITH & NEPHEW WOUND MANAGEMENT k060782 04/12/2006
acuson x300 diagnostic ultrasound system SIEMENS MEDICAL SOLUTIONS USA, INC. k061946 07/21/2006
modification to acuson antares ultrasound system SIEMENS MEDICAL SOLUTIONS USA, INC. k063138 11/22/2006
axiom aristos fx plus SIEMENS MEDICAL SOLUTIONS USA INC. k061054 05/09/2006
dose verification system patient dosimetry system, models dvs-i-11, dvs insertion tool, dvs-d-a, dvs dosimeter SICEL TECHNOLOGIES, INC. k061051 06/13/2006
rhythm touch q 2-way SHOCKIM ENTERPRISES, LTD. k063743 05/24/2007

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