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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K872766
Device Name IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
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 Number870.3610
Classification Product Code
DXY  
Date Received07/14/1987
Decision Date 11/04/1987
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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