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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 K060655
Device Name SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H
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 Received03/13/2006
Decision Date 04/04/2006
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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