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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 K890412
Device Name MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
Applicant
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541 -0617
Applicant Contact KATHLEEN M CHESTER
Correspondent
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541 -0617
Correspondent Contact KATHLEEN M CHESTER
Regulation Number870.3680
Classification Product Code
DTB  
Date Received01/24/1989
Decision Date 03/28/1989
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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