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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 K851915
Device Name CURING LIGHT
Applicant
Technology, Inc.
Balligomingo Rd.
P.O. Box 71
West Conshohocken,  PA  19428
Applicant Contact ART KNOPP
Correspondent
Technology, Inc.
Balligomingo Rd.
P.O. Box 71
West Conshohocken,  PA  19428
Correspondent Contact ART KNOPP
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received05/01/1985
Decision Date 07/09/1985
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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