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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K001413
Device Name ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
Applicant
Biotronik, Inc.
6024 SW Jean Rd. B4
Lake Oswego,  OR  97035
Applicant Contact Jon Brumbaugh
Correspondent
Biotronik, Inc.
6024 SW Jean Rd. B4
Lake Oswego,  OR  97035
Correspondent Contact Jon Brumbaugh
Regulation Number870.3680
Classification Product Code
DTB  
Date Received05/04/2000
Decision Date 06/02/2000
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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