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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K926340
Device Name NEW LEAD INTRODUCER KITS, VARIOUS MODELS
Applicant
Telectronics Pacing Systems, Inc.
C/O Richard S. Morey
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact CANDACE F HOWELL
Correspondent
Telectronics Pacing Systems, Inc.
C/O Richard S. Morey
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact CANDACE F HOWELL
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/17/1992
Decision Date 05/27/1993
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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