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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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implex continuum knee system-patellar components, model 04-xx-yyyyy IMPLEX CORP. k004013 01/25/2001
impra carboflo eptfe vascular grafts IMPRA, INC. k004012 05/14/2001
impra carboflo vascular graft, impra carboflo vascular grafts for a-v access IMPRA, INC. k004011 03/27/2001
indigo diffuser-tip fiberoptic with temperature sensing option, model lf001 ETHICON ENDO-SURGERY, INC. k003953 03/16/2001
indigo laseroptic treatment system ETHICON ENDO-SURGERY, INC. k003952 03/16/2001
injectrite-c15 and injectrite-c30 STERLING MEDIVATIONS, INC. k002127 12/29/2000
inplant orthodontic anchor system NOBEL BIOCARE UAS INC k000643 09/07/2000
insufflation needle, model r65-933 A & A MEDICAL, INC. k000027 04/03/2000
insyte catheter, insyte autoguard catheter BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. k000235 04/05/2000
integra oxygen concentrators model 6400-om SEQUAL TECHNOLOGIES, INC. k003472 06/04/2001

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