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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K974553
Device Name 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)
Applicant
3M Healthcare
3m Center, Bldg. 275-3e-08
P.O. Box 33275
St. Paul,  MN  55133
Applicant Contact LINDA JOHNSEN
Correspondent
3M Healthcare
3m Center, Bldg. 275-3e-08
P.O. Box 33275
St. Paul,  MN  55133
Correspondent Contact LINDA JOHNSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/17/1997
Decision Date 02/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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