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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
510(k) Number K011988
Device Name SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
Applicant
Cardiofocus, Inc.
10 Commerce Way
Norton,  MA  02766
Applicant Contact JOSEPH CURTIS
Correspondent
Cardiofocus, Inc.
10 Commerce Way
Norton,  MA  02766
Correspondent Contact JOSEPH CURTIS
Regulation Number878.4400
Classification Product Code
OCL  
Date Received06/26/2001
Decision Date 09/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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