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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 K072329
Device Name SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
Original Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego,  OR  97035
Original Contact jon brumbaugh
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Codes
DQX   DRE  
Date Received08/21/2007
Decision Date 03/25/2008
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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