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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 K974445
Device Name 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
Applicant
3M HEALTH CARE
3M CENTER, BLDG. 275-3E-08
P.O. BOX 33275
ST. PAUL,  MN  55133 -1000
Applicant Contact LINDA JOHNSEN
Correspondent
3M HEALTH CARE
3M CENTER, BLDG. 275-3E-08
P.O. BOX 33275
ST. PAUL,  MN  55133 -1000
Correspondent Contact LINDA JOHNSEN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received11/25/1997
Decision Date 07/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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