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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 K031011
Device Name LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
Original Applicant
VALLEYLAB, INC.
5920 longbow dr.
boulder,  CO  80301
Original Contact herbert vinson
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/31/2003
Decision Date 05/29/2003
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
Recalls CDRH Recalls
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