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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 K934899
Device Name BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
Applicant
Telectronics Pacing Systems, Inc.
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact CANDANCE F HOWELL
Correspondent
Telectronics Pacing Systems, Inc.
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact CANDANCE F HOWELL
Regulation Number870.3620
Classification Product Code
DTD  
Date Received10/14/1993
Decision Date 05/12/1994
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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