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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K974483
Device Name NTL-FLOW
Applicant
Bisco, Inc.
1100 W. Irving Park Rd.
Schaumburg,  IL  60193
Applicant Contact JAMES L SANDRIK
Correspondent
Bisco, Inc.
1100 W. Irving Park Rd.
Schaumburg,  IL  60193
Correspondent Contact JAMES L SANDRIK
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/26/1997
Decision Date 02/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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