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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 K841225
Device Name PULSE GENERATOR 689, 689B & 689L
Applicant
Siemens Elema AB
Burditt, Bowles & Radzius
135 S. Lasalle St.
Chicago,  IL  60603
Applicant Contact JOSEPH R RADZIUS
Correspondent
Siemens Elema AB
Burditt, Bowles & Radzius
135 S. Lasalle St.
Chicago,  IL  60603
Correspondent Contact JOSEPH R RADZIUS
Regulation Number870.3610
Classification Product Code
DXY  
Date Received03/22/1984
Decision Date 12/03/1984
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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