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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical Coagulation For Aesthetic
510(k) Number K083352
Device Name VEINWAVE, TC3000
Applicant
Newlands Clinical Trials, Ltd.
220 River Rd.
Claremont,  NH  03743
Applicant Contact WILLIAM GREENROSE
Correspondent
Newlands Clinical Trials, Ltd.
220 River Rd.
Claremont,  NH  03743
Correspondent Contact WILLIAM GREENROSE
Regulation Number878.4400
Classification Product Code
ONQ  
Date Received11/13/2008
Decision Date 06/12/2009
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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