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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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protein s ac DADE BEHRING, INC. k022290 08/27/2002
5.0 mm diameter polyaxial screws (moss miami 6.35mm system) DEPUY ACROMED k022623 08/27/2002
tempfix external fixation system DEPUY ORTHOPAEDICS, INC. k021933 08/26/2002
ceranum 87 LUCIUS METALS COM. k021947 08/26/2002
athoscan for the athos laser constans cooling hand piece for the athos laser QUANTEL MEDICAL k021650 08/16/2002
synthes craniofacial plates SYNTHES (USA) k021642 08/14/2002
single step biopsy device, single step surgical handle, single step driver, single step holders SENORX, INC. k021707 08/14/2002
modification to olympus integrated endosurgery system endoalpha OLYMPUS OPTICAL CO., LTD. k022270 08/14/2002
modification to isola spinal system DEPUY ACROMED k022285 08/13/2002
ems piezon master 600 ELECTRO MEDICAL SYSTEMS SA k022328 08/13/2002

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