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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 K780113
Device Name CARDIAC PULSE GENERATOR, MODEL 160B
Applicant
Telectronics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Telectronics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.3610
Classification Product Code
DXY  
Date Received01/19/1978
Decision Date 02/13/1978
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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