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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K994048
Device Name PORTABLE LIGHT CURING UNIT
Applicant
Gregory S. Jacob, D.D.S.
9672 Reading Cir.
Des Plains,  IL  60016
Applicant Contact GREGORY S JACOB
Correspondent
Gregory S. Jacob, D.D.S.
9672 Reading Cir.
Des Plains,  IL  60016
Correspondent Contact GREGORY S JACOB
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received11/26/1999
Decision Date 01/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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