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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 K112482
Device Name SELECTRA SLITTER TOOL
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 Received08/29/2011
Decision Date 09/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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