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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 K902889
Device Name A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.
Applicant
Biotronik, GmbH & Co.
6024 Southwest Jean Rd.
Unit B4
Lake Oswego,  OR  97035
Applicant Contact STOUT, MD
Correspondent
Biotronik, GmbH & Co.
6024 Southwest Jean Rd.
Unit B4
Lake Oswego,  OR  97035
Correspondent Contact STOUT, MD
Regulation Number870.3620
Classification Product Code
DTD  
Date Received07/02/1990
Decision Date 08/23/1990
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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