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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, tooth shade, resin
510(k) Number K760417
Device Name LEE-FILL ULTRAVIOLET-CURED REST. MAT.
Applicant
LEE PHARMACEUTICALS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LEE PHARMACEUTICALS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/09/1976
Decision Date 08/23/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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