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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 K962690
Device Name E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE
Applicant
Valleylab, Inc.
5920 Longbow Dr.
P.O. Box 9015
Boulder,  CO  80301
Applicant Contact PEGGY WALLINE
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
P.O. Box 9015
Boulder,  CO  80301
Correspondent Contact PEGGY WALLINE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/11/1996
Decision Date 11/04/1996
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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