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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 K955836
Device Name VALLEYLAB COATED ELECTRODES
Applicant
Valleylab, Inc.
5920 Longbow Dr.
P.O. Box 9015
Boulder,  CO  80301
Applicant Contact HERBERT VINSON
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
P.O. Box 9015
Boulder,  CO  80301
Correspondent Contact HERBERT VINSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/26/1995
Decision Date 02/01/1996
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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