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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K890895
Device Name IMPLANTABLE ADAPTOR 033-380
Applicant
Telectronics, Inc.
7400 Tuscon Way
Englewood,  CO  80112
Applicant Contact DUANE A SCHULTZ
Correspondent
Telectronics, Inc.
7400 Tuscon Way
Englewood,  CO  80112
Correspondent Contact DUANE A SCHULTZ
Regulation Number870.3620
Classification Product Code
DTD  
Date Received02/22/1989
Decision Date 03/06/1990
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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