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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 K903918
Device Name MODEL 1850 ELECTRODE
Applicant
Medtronic Vascular
60 Newark St.
Haverhill,  MA  01830
Applicant Contact JANICE M PEVIDE
Correspondent
Medtronic Vascular
60 Newark St.
Haverhill,  MA  01830
Correspondent Contact JANICE M PEVIDE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received08/24/1990
Decision Date 10/31/1990
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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