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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 K000690
Device Name 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
Applicant
Minnesota Mining and Mfg. Co.
3m Center
St. Paul,  MN  55144
Applicant Contact LINDA JOHNSON
Correspondent
Minnesota Mining and Mfg. Co.
3m Center
St. Paul,  MN  55144
Correspondent Contact LINDA JOHNSON
Regulation Number870.2360
Classification Product Code
DRX  
Date Received02/29/2000
Decision Date 05/17/2000
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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