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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 K063025
Device Name LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,
Applicant
Lina Medical Aps
1289 N Fordham Blvd.
Suite A-128
Chapel Hill,  NC  27517
Applicant Contact WALT BRITTLE
Correspondent
Lina Medical Aps
1289 N Fordham Blvd.
Suite A-128
Chapel Hill,  NC  27517
Correspondent Contact WALT BRITTLE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/02/2006
Decision Date 12/01/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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