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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
FOIA Releasable 510(k) K031011
Device Name LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
Applicant
VALLEYLAB, INC.
5920 LONGBOW DR.
BOULDER,  CO  80301
Applicant Contact HERBERT VINSON
Correspondent
VALLEYLAB, INC.
5920 LONGBOW DR.
BOULDER,  CO  80301
Correspondent 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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