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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tools, Pacemaker Service
510(k) Number K781179
Device Name WRENCH, GEXAGON, DRIVER
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 Number870.3730
Classification Product Code
DTF  
Date Received07/14/1978
Decision Date 07/27/1978
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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