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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 K034024
Device Name TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS
Applicant
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG,  IL  60193
Applicant Contact BENJAMIN LICHTENWALNER
Correspondent
BISCO, INC.
1100 WEST IRVING PARK RD.
SCHAUMBURG,  IL  60193
Correspondent Contact BENJAMIN LICHTENWALNER
Regulation Number872.3760
Classification Product Code
EBI  
Date Received12/29/2003
Decision Date 03/19/2004
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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