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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K032597
Device Name BISCEM GI
Applicant
Bisco, Inc.
1100 W. Irving Park Rd.
Schaumburg,  IL  60193
Applicant Contact KATHY JOUNG
Correspondent
Bisco, Inc.
1100 W. Irving Park Rd.
Schaumburg,  IL  60193
Correspondent Contact KATHY JOUNG
Regulation Number872.3275
Classification Product Code
EMA  
Subsequent Product Codes
DYH   KLE  
Date Received08/22/2003
Decision Date 11/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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