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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 K944244
Device Name MODEL E278OR-ASP SERIES RETRACTABLE
Applicant
Valleylab, Inc.
5920 Longbow Dr.
P.O. Box 9015
Boulder,  CO  80301
Applicant Contact JULIE ROSS
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
P.O. Box 9015
Boulder,  CO  80301
Correspondent Contact JULIE ROSS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/01/1994
Decision Date 11/30/1994
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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