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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K070315
Device Name LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
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 Number884.4160
Classification Product Code
KNF  
Date Received02/01/2007
Decision Date 10/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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