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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 K062539
Device Name NCONTACT COAGULATION SYSTEM KIT
Applicant
Ncontact Surgical, Inc.
2880 Slater Rd.
Suite 103
Morrisville,  NC  27560
Applicant Contact JANE RICUPERO
Correspondent
Ncontact Surgical, Inc.
2880 Slater Rd.
Suite 103
Morrisville,  NC  27560
Correspondent Contact JANE RICUPERO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/29/2006
Decision Date 12/01/2006
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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