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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K871312
Device Name FIBREFLEX
Applicant
Biomedical Composites, Ltd.
N89 W16785 Appleton Ave.
Menomonee Falls,  WI  53051
Applicant Contact RICHARD MULLARKY,DDS
Correspondent
Biomedical Composites, Ltd.
N89 W16785 Appleton Ave.
Menomonee Falls,  WI  53051
Correspondent Contact RICHARD MULLARKY,DDS
Regulation Number872.3760
Classification Product Code
EBI  
Date Received04/01/1987
Decision Date 04/15/1987
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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