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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K926238
Device Name BISCO PORCELAIN ETCHING GEL
Applicant
Bisco, Inc.
1500 W. Thorndale Ave.
Itasca,  IL  60143
Applicant Contact BYOUNG I SUH
Correspondent
Bisco, Inc.
1500 W. Thorndale Ave.
Itasca,  IL  60143
Correspondent Contact BYOUNG I SUH
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/11/1992
Decision Date 03/31/1993
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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