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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K894267
Device Name OPUS MODELS 4033 AND 4034
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 Number870.3610
Classification Product Code
DXY  
Date Received06/22/1989
Decision Date 09/20/1989
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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