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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 K853520
Device Name LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD
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 Number870.3680
Classification Product Code
DTB  
Date Received08/22/1985
Decision Date 10/08/1985
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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