FDA 510(k) Application Details - K955329

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K955329
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant CONFI-DENTAL PRODUCTS CO.
416 SOUTH TAYLOR AVE.
LOUISVILLE, CO 80027-3028 US
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Contact SHARON A LUTTON
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 11/20/1995
Decision Date 03/28/1996
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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