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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K941015
Device Name ORMCO SYSTEM 1+ (TM)
Applicant
Ormco Corp.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact JEFFREY A ANDERSON
Correspondent
Ormco Corp.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact JEFFREY A ANDERSON
Regulation Number872.3750
Classification Product Code
DYH  
Date Received03/03/1994
Decision Date 03/31/1994
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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