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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 K853221
Device Name SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401
Applicant
Telectronics, Inc.
40 Crane Hill Rd.
Suffield,  CT  06078
Applicant Contact WILLIAM C NEALON
Correspondent
Telectronics, Inc.
40 Crane Hill Rd.
Suffield,  CT  06078
Correspondent Contact WILLIAM C NEALON
Regulation Number870.3680
Classification Product Code
DTB  
Date Received08/01/1985
Decision Date 09/17/1985
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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