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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
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modification to townley transfacepedicular screw fixation system MEDTRONIC SOFAMOR DANEK, INC. k021705 07/24/2002
vectorsonic, model vu-200 METRON MEDICAL AUSTRALIA PTY LTD k020119 07/22/2002
subdermal needle electrode for electroencephalography, models pro-e12saf and den-12saf THE ELECTRODE STORE, INC. k020910 07/19/2002
jas hdl cholesterol (automated) reagent JAS Diagnostics, Inc. k021671 07/19/2002
lactosorb mini interference screw BIOMET ORTHOPEDICS, INC. k021254 07/17/2002
3d knee ENCORE ORTHOPEDICS, INC. k020114 07/12/2002
roche online gentamicin ROCHE DIAGNOSTICS CORP. k020704 07/12/2002
cypress medical products, lp disposable vaginal speculum, non-metal CYPRESS MEDICAL PRODUCTS, LTD. k021676 07/12/2002
platelet concentrate separation kit for celsep centrifuge system BIOMET, INC. k021927 07/12/2002
monarch spine system DEPUY ACROMED k021335 07/11/2002

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