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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 K884278
Device Name IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436
Applicant
Telectronics, Inc.
7400 Tuscon Way
Englewood,  CO  80112
Applicant Contact DUANE SCHULTZ
Correspondent
Telectronics, Inc.
7400 Tuscon Way
Englewood,  CO  80112
Correspondent Contact DUANE SCHULTZ
Regulation Number870.3680
Classification Product Code
DTB  
Date Received10/12/1988
Decision Date 12/15/1988
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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