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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 K033320
Device Name SCOUT PRO
Applicant
BIOTRONIK, INC.
6024 JEAN ROAD
LAKE OSWEGO,  OR  97035
Applicant Contact Jon Brumbaugh
Correspondent
BIOTRONIK, INC.
6024 JEAN ROAD
LAKE OSWEGO,  OR  97035
Correspondent Contact Jon Brumbaugh
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/15/2003
Decision Date 11/19/2003
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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