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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K954388
Device Name CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
Applicant
Conmedcorp
P.O. Box 1408
Dayton,  OH  45401 -1408
Applicant Contact IRA D DUESLER, JR.
Correspondent
Conmedcorp
P.O. Box 1408
Dayton,  OH  45401 -1408
Correspondent Contact IRA D DUESLER, JR.
Regulation Number870.2360
Classification Product Code
DRX  
Date Received09/19/1995
Decision Date 02/06/1996
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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