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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name external cleaning solution
510(k) Number K163171
Device Name CeraClean
Applicant
Bisco, Inc.
1100 West Irving Park Road
Schaumburg,  IL  60193
Applicant Contact Ryan Hobson
Correspondent
Bisco, Inc.
1100 West Irving Park Road
Schaumburg,  IL  60193
Correspondent Contact Ryan Hobson
Regulation Number872.3260
Classification Product Code
PME  
Date Received11/14/2016
Decision Date 04/14/2017
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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