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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 K041587
Device Name LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500
Applicant
Valleylab
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact CHARLES COPPERBERG
Correspondent
Valleylab
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact CHARLES COPPERBERG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/14/2004
Decision Date 09/28/2004
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
Predetermined Change
Control Plan Authorized		 No
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