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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 K863898
Device Name MULTILITH 3 MODELS 1350, 3350, 1370, 3370
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 Received10/07/1986
Decision Date 02/10/1987
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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