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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name U.V. Light, Tlc
510(k) Number K771486
Device Name DUAL LAB-LITE LIGHT BOX
Applicant
Technilab
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Technilab
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2270
Classification Product Code
DJS  
Date Received08/01/1977
Decision Date 08/22/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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