FDA 510(k) Application Details - K961417

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K961417
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant GC AMERICA, INC.
3737 WEST 127TH ST.
ALSIP, IL 60803 US
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Contact TERRY L JORTIZ
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 04/12/1996
Decision Date 05/24/1996
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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