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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K874557
Device Name BISCO PORCELAIN REPAIR KIT
Applicant
Bisco, Inc.
3010-J Woodcreek Dr.
Downers Grove,  IL  60515
Applicant Contact BYOUNG I SUH
Correspondent
Bisco, Inc.
3010-J Woodcreek Dr.
Downers Grove,  IL  60515
Correspondent Contact BYOUNG I SUH
Regulation Number872.3765
Classification Product Code
EBC  
Date Received11/04/1987
Decision Date 01/28/1988
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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