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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 K890350
Device Name VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
Applicant
Telectronics, Inc.
7400 Tuscon Way
Englewood,  CO  80112
Applicant Contact A SCHULTZ
Correspondent
Telectronics, Inc.
7400 Tuscon Way
Englewood,  CO  80112
Correspondent Contact A SCHULTZ
Regulation Number870.3680
Classification Product Code
DTB  
Date Received11/08/1988
Decision Date 02/02/1989
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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