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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 K954389
Device Name CONMED ECG/EKG ELECTRODES
Applicant
Conmedcorp
310 Broad St.
Utica,  NY  13501 -1203
Applicant Contact IRA D DUESLER, JR.
Correspondent
Conmedcorp
310 Broad St.
Utica,  NY  13501 -1203
Correspondent Contact IRA D DUESLER, JR.
Regulation Number870.2360
Classification Product Code
DRX  
Date Received09/19/1995
Decision Date 05/16/1996
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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