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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 K926481
Device Name VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET
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
GEI  
Date Received12/29/1992
Decision Date 02/12/1994
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
Recalls CDRH Recalls
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