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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Metal, Orthodontic
510(k) Number K904091
Device Name TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO
Applicant
Lancer Orthodontics, Inc.
6050 Avenida Encinas
P.O. Box 819
Carlsbad,  CA  92008
Applicant Contact MIKE EKINAKA
Correspondent
Lancer Orthodontics, Inc.
6050 Avenida Encinas
P.O. Box 819
Carlsbad,  CA  92008
Correspondent Contact MIKE EKINAKA
Regulation Number872.5410
Classification Product Code
EJF  
Date Received09/06/1990
Decision Date 11/05/1990
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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