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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vein Location, Liquid Crystal
510(k) Number K101838
Device Name VTS1000
Applicant
Vuetek Scientific, LLC
1733 Canton Lane
Suite B
Marietta,  GA  30062 -2679
Applicant Contact PAUL SUMNER
Correspondent
Vuetek Scientific, LLC
1733 Canton Lane
Suite B
Marietta,  GA  30062 -2679
Correspondent Contact PAUL SUMNER
Regulation Number880.6970
Classification Product Code
KZA  
Date Received07/01/2010
Decision Date 02/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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