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U.S. Department of Health and Human Services

510(K) Premarket Notification

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crosspoint transaccess catheter, model ta-xp-001 TRANS VASCULAR INCORPORATED k031920 07/23/2003
linical chemistry calibration verifiers levels a - e for beckman coulter synchron systems CLINIQA CORPORATION k031921 08/25/2003
captiva blood containment device cn100, can19t71w MERIT MEDICAL SYSTEMS, INC. k031922 10/01/2003
amniolens BIO-TISSUE, INC. k032104 12/12/2003
endohelix endarterectomy device ENDARX, INC. k032105 10/30/2003
starbond dental bonding alloys STAR REFINING PRECIOUS METALS SOUTH AFRICA k032106 08/25/2003
search evolution (lc) total knee system (porous coated) AESCULAP, INC. k032108 01/15/2004
proclass press fit hip stem STELKAST COMPANY k032110 09/22/2003
acuson cv70 cardiovascular system SIEMENS MEDICAL SOLUTIONS USA, INC. k032111 07/18/2003
p0rtex reinforced tracheal tube (cuffed and uncuffed) PORTEX LTD. k032112 01/26/2004

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