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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K844271
Device Name MODEL 479-01 PACING LEAD
Applicant
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541 -0617
Applicant Contact DAVID MAKANANI
Correspondent
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541 -0617
Correspondent Contact DAVID MAKANANI
Regulation Number870.3680
Classification Product Code
DTB  
Date Received11/05/1984
Decision Date 03/28/1985
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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