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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 K926414
Device Name VALLEYLAB MACROBIPOLAR FORCEPS HANDPIECE, E3200
Applicant
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact PEGGY WILLINE
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact PEGGY WILLINE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/23/1992
Decision Date 05/17/1993
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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