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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 K101282
Device Name SCOUTPRO HEMOSTATIC VALVE
Original Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego,  OR  97035
Original Contact jon brumbaugh
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/06/2010
Decision Date 07/21/2010
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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