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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 K951328
Device Name LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD
Applicant
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Applicant Contact MARVIN SNEDEKER
Correspondent
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Correspondent Contact MARVIN SNEDEKER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/23/1995
Decision Date 04/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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