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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 K882391
Device Name OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
Applicant
Ela Medical, Inc.
15245 Minnetonka Blvd.
Minnetonka,  MN  55345
Applicant Contact TOM S ANDERSON
Correspondent
Ela Medical, Inc.
15245 Minnetonka Blvd.
Minnetonka,  MN  55345
Correspondent Contact TOM S ANDERSON
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/10/1988
Decision Date 11/14/1988
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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