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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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somatom p30 ct systems SIEMENS MEDICAL SYSTEMS, INC. k013522 11/07/2001
handheld gamma finder (hgf) SILICON INSTRUMENTS GMHB k013751 02/06/2002
zirconia ceramic femoral head - 12/14 taper SMITH & NEPHEW, INC. k013989 12/19/2001
m2540 diagnostic ultrasound system, model m2540 PHILIPS MEDICAL SYSTEMS k014191 01/07/2002
medical administrator BARCO NV k020073 07/12/2002
datascope's 8fr. alt b iab; datascope's profile 8fr. alt b iab; datascope's true sheathless dl 9.5 fr. iab; datascope's DATASCOPE CORP. k020257 04/24/2002
chin electrode DYMEDIX, INC. k020468 04/16/2002
syncrus internal cardioversion system GUIDANT CORPORATION, CARDIAC SURGERY k020701 05/24/2002
rossmax automatic wrist blood pressure monitor, models b150 & q400 ROSSMAX INTERNATIONL LTD. k020897 08/06/2002
aurora ds SYNERON MEDICAL LTD. k021149 07/09/2002

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