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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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endohelix endarterectomy device ENDARX, INC. k032105 10/30/2003
bonesource hac fast setting cement STRYKER INSTRUMENTS k032366 10/30/2003
ge logiq 9 ultrasound bt03/iq, model 2375600-x GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC k032656 10/30/2003
stick flow STICK TECH LTD. k031341 10/29/2003
paragon medical surgical instrument delivery system various PARAGON MEDICAL, INC. k032119 10/29/2003
xtrak support catheter XTRAK MEDICAL INC. k032660 10/29/2003
sectra ids5 radiology workstation version 10.1 SECTRA AB k033088 10/29/2003
nxstage system one with cartridge express NXSTAGE MEDICAL, INC. k032356 10/28/2003
vivo 200 dps vivoscan version 2.0 oae audiometer VIVOSONIC, INC. k033108 10/27/2003
converge reti-lock multi-hole reinforcement cup CENTERPULSE ORTHOPEDICS, INC. k032348 10/24/2003

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