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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K905539
Device Name 3M 6830 ELECTRODE
Applicant
3M Healthcare
Medical Surgical Division
3m Center
St. Paul,  MN  55144
Applicant Contact JULIA L WANNAMAKER
Correspondent
3M Healthcare
Medical Surgical Division
3m Center
St. Paul,  MN  55144
Correspondent Contact JULIA L WANNAMAKER
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/11/1990
Decision Date 05/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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