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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K770884
Device Name ELHCTROCARDIOGRAPHIC CONNECTING WIRES
Applicant
Tronomed, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Tronomed, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2900
Classification Product Code
DSA  
Date Received05/16/1977
Decision Date 05/23/1977
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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