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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headgear, Extraoral, Orthodontic
510(k) Number K901958
Device Name GUARDIAN SAFE BOW
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 Number872.5500
Classification Product Code
DZB  
Date Received05/01/1990
Decision Date 07/30/1990
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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