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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 K942925
Device Name CONMED ANDOVER MED ECG ELECTRODES
Applicant
Conmed Andover Medical, Inc.
60 Newark St.
Haverhill,  MA  01832
Applicant Contact BRENDA CULLINANE
Correspondent
Conmed Andover Medical, Inc.
60 Newark St.
Haverhill,  MA  01832
Correspondent Contact BRENDA CULLINANE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received06/22/1994
Decision Date 07/20/1994
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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