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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 K981433
Device Name ORTHODONTIC BRACES
Applicant
Midwest Orthodontic Mfg.
4570 Progress Dr.
Columbus,  IN  47201
Applicant Contact JEFFREY L FASNACHT
Correspondent
Midwest Orthodontic Mfg.
4570 Progress Dr.
Columbus,  IN  47201
Correspondent Contact JEFFREY L FASNACHT
Regulation Number872.5470
Classification Product Code
DYW  
Date Received04/20/1998
Decision Date 06/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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