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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 K101776
Device Name SCOUTPRO ACS
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 Received06/25/2010
Decision Date 07/23/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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