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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 K051330
Device Name UVBIOTEK MODELS 3200B AND 4000B
Applicant
MEDTEK LIGHTING CORPORATION
2840 SCHERER DRIVE N.
SAINT PETERSBURG,  FL  33716
Applicant Contact ROBERT T WAGNER
Correspondent
MEDTEK LIGHTING CORPORATION
2840 SCHERER DRIVE N.
SAINT PETERSBURG,  FL  33716
Correspondent Contact ROBERT T WAGNER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received05/20/2005
Decision Date 11/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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