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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 K905446
Device Name MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE
Applicant
MEDTRONIC ANDOVER MEDICAL, INC.
60 NEWARK ST.
HAVERHILL,  MA  01830
Applicant Contact DAWN E SISSOM
Correspondent
MEDTRONIC ANDOVER MEDICAL, INC.
60 NEWARK ST.
HAVERHILL,  MA  01830
Correspondent Contact DAWN E SISSOM
Regulation Number870.2360
Classification Product Code
DRX  
Date Received12/05/1990
Decision Date 02/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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