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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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Applicant
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510(K)
Number
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Decision
Date
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zoll m series with rectilinear bi-phasic option (m series bi-phasic) ZOLL MEDICAL CORP. k032439 11/05/2003
zoll autoclavable internal handles ZOLL MEDICAL CORP. k032691 11/13/2003
zoll m series etc02 loflo option ZOLL MEDICAL CORP. k042417 10/05/2004
zimmer ortho guidance systems- knee instruments ZIMMER, INC. k033011 02/12/2004
versys beaded fullcoat calcar hip prosthesis ZIMMER, INC. k033034 11/05/2003
ncb plating system ZIMMER GMBH k042695 10/29/2004
cls spotorno stem ZIMMER AUSTIN, INC. k042249 09/15/2004
athena multi-lyte ana-ii test system ZEUS SCIENTIFIC, INC. k042416 10/08/2004
x-2 implant abutment; bar male; distal extension male ZEST ANCHORS, INC. k042466 11/24/2004
wu's 3-wheeled neo scooter, model wt-m3jr WU'S TECH CO., LTD. k033032 11/10/2003

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