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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K955333
Device Name SPIRIT MB
Applicant
ORMCO CORP.
1332 SOUTH LONE HILL AVE.
GLENDORA,  CA  91740
Applicant Contact LARRY WILLS
Correspondent
ORMCO CORP.
1332 SOUTH LONE HILL AVE.
GLENDORA,  CA  91740
Correspondent Contact LARRY WILLS
Regulation Number872.5470
Classification Product Code
DYW  
Date Received11/21/1995
Decision Date 01/04/1996
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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