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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 K970796
Device Name 3M RED DOT 2560 & 2570 MONITORING ELECTRODES
Applicant
3M HEALTH CARE
P.O. BOX 33275
3M CENTER, 275-3E-08
ST. PAUL,  MN  55144 -1000
Applicant Contact LINDA JOHNSEN
Correspondent
3M HEALTH CARE
P.O. BOX 33275
3M CENTER, 275-3E-08
ST. PAUL,  MN  55144 -1000
Correspondent Contact LINDA JOHNSEN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received03/04/1997
Decision Date 04/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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