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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 K043273
Device Name LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS
Applicant
VALLEYLAB
5920 LONGBOW DR.
BOULDER,  CO  80301
Applicant Contact HERBERT VINSON
Correspondent
VALLEYLAB
5920 LONGBOW DR.
BOULDER,  CO  80301
Correspondent Contact HERBERT VINSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/26/2004
Decision Date 01/05/2005
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
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