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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 K933758
Device Name REGENCY PLUS BRACKET
Applicant
Mid-American Dental Specialties, Inc.
9525 S. 79th Ave.
Hickory Hills,  IL  60457
Applicant Contact DAVID BROSIUS
Correspondent
Mid-American Dental Specialties, Inc.
9525 S. 79th Ave.
Hickory Hills,  IL  60457
Correspondent Contact DAVID BROSIUS
Regulation Number872.5410
Classification Product Code
EJF  
Date Received08/03/1993
Decision Date 01/18/1994
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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