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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Pacemaker Electrode Function
510(k) Number K073230
Device Name MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
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 Number870.3720
Classification Product Code
DTA  
Subsequent Product Codes
DTC   DTE  
Date Received11/15/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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