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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 K904255
Device Name FOCUS T41,T41F,T43, T43F,T44F
Applicant
Elamedical
15245 Minnetonka Blvd.
Minnetonka,  MN  55345
Applicant Contact PAUL KOHL
Correspondent
Elamedical
15245 Minnetonka Blvd.
Minnetonka,  MN  55345
Correspondent Contact PAUL KOHL
Regulation Number870.3680
Classification Product Code
DTB  
Date Received09/17/1990
Decision Date 01/18/1991
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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