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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 K884394
Device Name PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
Applicant
Ela Medical, Inc.
15245 Minnetonka Blvd.
Minnetonka,  MN  55345
Applicant Contact PAUL KOHL
Correspondent
Ela Medical, Inc.
15245 Minnetonka Blvd.
Minnetonka,  MN  55345
Correspondent Contact PAUL KOHL
Regulation Number870.3680
Classification Product Code
DTB  
Date Received10/14/1988
Decision Date 12/08/1988
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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