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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 K071819
Device Name NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
Applicant
Ncontact Surgical, Inc.
1001 Aviation Pkwy., Suite 400
Morrisville,  NC  27560
Applicant Contact JANE RICUPERO
Correspondent
Ncontact Surgical, Inc.
1001 Aviation Pkwy., Suite 400
Morrisville,  NC  27560
Correspondent Contact JANE RICUPERO
Regulation Number878.4400
Classification Product Code
OCL  
Date Received07/03/2007
Decision Date 07/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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