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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 K080988
Device Name SCOUTPRO CS LEAD INTRODUCER SYSTEM
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 Received04/07/2008
Decision Date 05/07/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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