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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K955740
Device Name GLUFLORMA
Applicant
Midwest Orthodontic Mfg.
4570 Progress Dr.
Columbus,  IN  47201
Applicant Contact JEFFERY L FASNACHT
Correspondent
Midwest Orthodontic Mfg.
4570 Progress Dr.
Columbus,  IN  47201
Correspondent Contact JEFFERY L FASNACHT
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/15/1995
Decision Date 02/08/1996
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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