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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K970204
Device Name BK-A; BK-B; BK-IS SEALING CAP
Applicant
Biotronik, Inc.
6024 SW Jean Rd. B4
Lake Oswego,  OR  97035 -3594
Applicant Contact Joseph J Schwoebel
Correspondent
Biotronik, Inc.
6024 SW Jean Rd. B4
Lake Oswego,  OR  97035 -3594
Correspondent Contact Joseph J Schwoebel
Regulation Number870.3620
Classification Product Code
DTD  
Date Received01/21/1997
Decision Date 04/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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