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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Materials, Repair Or Replacement, Pacemaker
510(k) Number K913919
Device Name UNIVERSAL TERMINAL CAP, 3.2MM
Applicant
Telectronics Pacing Systems, Inc.
7400 S. Tucson Way
Englewood,  CO  80112
Applicant Contact DUANE A SCHULTZ
Correspondent
Telectronics Pacing Systems, Inc.
7400 S. Tucson Way
Englewood,  CO  80112
Correspondent Contact DUANE A SCHULTZ
Regulation Number870.3710
Classification Product Code
KFJ  
Date Received09/03/1991
Decision Date 12/31/1991
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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