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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 K900824
Device Name FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)
Applicant
Midwest Orthodontic Mfg.
680 N. Lake Shore Dr.
Suite 901
Chicago,  IL  60611
Applicant Contact AN-SHIH CHENG
Correspondent
Midwest Orthodontic Mfg.
680 N. Lake Shore Dr.
Suite 901
Chicago,  IL  60611
Correspondent Contact AN-SHIH CHENG
Regulation Number872.5410
Classification Product Code
EJF  
Date Received02/21/1990
Decision Date 05/22/1990
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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