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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 K910608
Device Name PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
Applicant
Biotronik, GmbH & Co.
6024 Southwest Jean Rd.
Unit B4
Lake Oswego,  OR  97035 -5369
Applicant Contact Scott J Mindrebo
Correspondent
Biotronik, GmbH & Co.
6024 Southwest Jean Rd.
Unit B4
Lake Oswego,  OR  97035 -5369
Correspondent Contact Scott J Mindrebo
Regulation Number870.3680
Classification Product Code
DTB  
Date Received02/12/1991
Decision Date 07/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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