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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 K880392
Device Name ORTHOLUX VISIBLE LIGHT CURING UNIT
Applicant
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016 -5097
Applicant Contact MARLYN SCHEFF
Correspondent
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016 -5097
Correspondent Contact MARLYN SCHEFF
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received01/29/1988
Decision Date 04/07/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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