FDA 510(k) Application Details - K033751

Device Classification Name Sealant, Pit And Fissure, And Conditioner

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510(K) Number K033751
Device Name Sealant, Pit And Fissure, And Conditioner
Applicant HARRY J. BOSWORTH CO.
7227 NORTH HAMLIN AVE.
SKOKIE, IL 60076 US
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Contact MILDRED M GOLDSTEIN
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Regulation Number 872.3765

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Classification Product Code EBC
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Date Received 12/01/2003
Decision Date 02/05/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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