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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 K885086
Device Name TIN COATED NITI ORTHODONTIC ARCH WIRES
Applicant
Flexmedics
620 Ford Ctr., 420 N. Fifth
St.
Minneapolis,  MN  55401
Applicant Contact JAMES D STICE
Correspondent
Flexmedics
620 Ford Ctr., 420 N. Fifth
St.
Minneapolis,  MN  55401
Correspondent Contact JAMES D STICE
Regulation Number872.5410
Classification Product Code
EJF  
Date Received12/09/1988
Decision Date 01/10/1989
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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