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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 K994028
Device Name FLIPO XENON CURING LIGHT
Applicant
Lokki
344 Annabelle Pt. Rd.
Centercille,  MA  02632
Applicant Contact HILLARD W WELCH
Correspondent
Lokki
344 Annabelle Pt. Rd.
Centercille,  MA  02632
Correspondent Contact HILLARD W WELCH
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received11/26/1999
Decision Date 01/12/2000
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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