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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K060655
Device Name SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; "HOOK" GUIDING CATHETER, MODELS 342 263; "MULTI-PURPOSE H
Original Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego,  OR  97035
Original Contact jon brumbaugh
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/14/2006
Decision Date 04/04/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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