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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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zoomcam ld-10 intraoral camera and accessories ROLENCE ENTEPRISE, INC. k043325 02/11/2005
zoll m series with rectilinear bi-phasic option (m series bi-phasic) ZOLL MEDICAL CORP. k032439 11/05/2003
zoll m series etc02 loflo option ZOLL MEDICAL CORP. k042417 10/05/2004
zoll autoclavable internal handles ZOLL MEDICAL CORP. k032691 11/13/2003
zodiac polyaxial spinal fixation system ALPHATEC/NEXMED k042673 10/27/2004
zimmer ortho guidance systems- knee instruments ZIMMER, INC. k033011 02/12/2004
xltek connex ip headbox, model 1054 EXCEL TECH. LTD. k042223 09/16/2004
xenform soft tissue repair matrix TEI BIOSCIENCES INC. k051190 06/10/2005
xawex g 100 WIELAND DENTAL + TECHNIK GMBH & CO. KG k050903 06/23/2005
x-leonardo SIEMENS MEDICAL SOLUTIONS USA, INC. k042995 11/24/2004

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