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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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micrus microcoil delivery system, mds03 MICRUS CORP. k002056 01/11/2001
radianalyzer, model 12710 RADI MEDICAL SYSTEMS AB k002067 01/11/2001
synthes (usa) resorbable tack system SYNTHES (USA) k000560 01/09/2001
kelo-cote topical gel ADVANCED BIO-TECHNOLOGIES, INC. k002488 01/05/2001
abx pentra 60c+ hematology analyzer ABX DIAGNOSTICS k003677 12/26/2000
breathing filter for disposable anesthesia breathing circuit SIMS PORTEX, INC. k002506 12/14/2000
acti-flex fluid delivery system or acti-flex f d s R-GROUP INTL. k001233 12/13/2000
orthomatrix, inc. cerclage system ORTHOMATRIX, INC. k001254 12/13/2000
hanger cranial band HANGER ORTHOPEDIC GROUP, INC. k001669 12/08/2000
zynergy featherpace transvenous bipolar catheter, model 04-x-02-3-10-3 ZCV ,INC. k002481 12/07/2000

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