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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 K821438
Device Name RED DOT MONITORING ELECTRODES #2260/65
Applicant
3M Company
8124 Pacific Ave.
White City,  OR  97503
Correspondent
3M Company
8124 Pacific Ave.
White City,  OR  97503
Regulation Number870.2360
Classification Product Code
DRX  
Date Received05/13/1982
Decision Date 05/25/1982
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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