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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K954900
Device Name 3M RED DOT ECG LEAD WIRES A
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 Number870.2900
Classification Product Code
DSA  
Date Received10/25/1995
Decision Date 07/15/1996
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
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