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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adhesive, bracket and tooth conditioner, resin
510(k) Number K083051
Device Name FLOWTAIN & FLOWTAIN LV
Applicant
RELIANCE ORTHODONTIC PRODUCTS, INC.
1540 WEST THORNDALE AVE.
ITASCA,  IL  60143
Applicant Contact PAULA WENDLAND
Correspondent
RELIANCE ORTHODONTIC PRODUCTS, INC.
1540 WEST THORNDALE AVE.
ITASCA,  IL  60143
Correspondent Contact PAULA WENDLAND
Regulation Number872.3750
Classification Product Code
DYH  
Subsequent Product Code
EBF  
Date Received10/14/2008
Decision Date 02/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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