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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 K062525
Device Name REPROCESSED LIGASURE VESSEL SEALER/DIVIDER
Applicant
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact MOIRA BARTON
Correspondent
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact MOIRA BARTON
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
NUJ  
Date Received08/28/2006
Decision Date 05/16/2007
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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