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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 K914003
Device Name MIDAS BRACKET
Applicant
Gold'N Braces, Inc.
2595 State Rd. 584, Suite 1
Palm Harbor,  FL  34684
Applicant Contact PAUL R DURYEA
Correspondent
Gold'N Braces, Inc.
2595 State Rd. 584, Suite 1
Palm Harbor,  FL  34684
Correspondent Contact PAUL R DURYEA
Regulation Number872.5410
Classification Product Code
EJF  
Date Received09/06/1991
Decision Date 12/16/1991
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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