FDA 510(k) Application Details - K962946

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K962946
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant BISCO, INC.
1500 W. THORNDALE AVE.
ITASCA, IL 60143 US
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Contact JAMES L SANDRIK
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 07/29/1996
Decision Date 09/03/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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