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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 K852430
Device Name SUPRIMA II MODEL 253-23
Applicant
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541 -0617
Applicant Contact LISA S JONES
Correspondent
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541 -0617
Correspondent Contact LISA S JONES
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/10/1985
Decision Date 07/17/1985
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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