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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Unit, Electrosurgical And Coagulation, With Accessories
510(k) Number K874794
Device Name E600B FOOTSWITCH
Applicant
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact PEGGY WALLINE
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact PEGGY WALLINE
Regulation Number878.4400
Classification Product Code
BWA  
Date Received11/23/1987
Decision Date 12/14/1987
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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