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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, ultraviolet, dermatological
510(k) Number K111049
Device Name MOBILE VERSA LIGHT
Applicant
MEDTEK LIGHTING CORP
1131 ANTHEM VIEW LANE
KNOXVILLE,  TN  37922
Applicant Contact ROBERT WAGNER
Correspondent
MEDTEK LIGHTING CORP
1131 ANTHEM VIEW LANE
KNOXVILLE,  TN  37922
Correspondent Contact ROBERT WAGNER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/15/2011
Decision Date 05/25/2012
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
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