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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 K811106
Device Name INTERMEDICS POLY FLEX ENDOCARDIAL PACING
Applicant
INTERMEDICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INTERMEDICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.3680
Classification Product Code
DTB  
Date Received04/23/1981
Decision Date 05/27/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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