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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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stratus cs d-dimer calpak calibrator, model cddmr-c DADE BEHRING, INC. k022977 11/27/2002
autolens cleaning and disinfecting unit AUTOLENS INC. k021699 12/16/2002
modification to vision sciences endosheath system VISION-SCIENCES, INC. k024095 01/09/2003
dermagrip-x powder free latex examination gloves with skin-care ingredients (vitamin a, vitamin b, oc-lipoic acid, eucal WRP ASIA PACIFIC SDN. BHD. k023490 01/16/2003
skintact ecg electrodes with kl 02 liquid gel LEONHARD LANG GMBH k024247 01/16/2003
scivolutions various antibacterial bandages SCIVOLUTIONS, INC k020318 02/03/2003
versys beaded fullcoat bowed revision hip prosthesis ZIMMER, INC. k030079 02/05/2003
hydropure portable exchange deionization (pedi) system; hydropure back-up pedi system HYDROPURE SYSTEMS, INC. k022747 02/11/2003
quandrox safeline hollow fiber membrane oxygenator, model hmo 2030 JOSTRA AG k030264 02/26/2003
oria cervical plates ORTHOTEC, L.L.C. k023377 03/04/2003

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