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FDA 510(k) Application Details - K040548
Device Classification Name
Adhesive, Bracket And Tooth Conditioner, Resin
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510(K) Number
K040548
Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
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
872.3750
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Classification Product Code
DYH
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More FDA Info for this Product Code
Date Received
03/02/2004
Decision Date
03/19/2004
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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