FDA 510(k) Application Details - K001446

Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin

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510(K) Number K001446
Device Name Adhesive, Bracket And Tooth Conditioner, Resin
Applicant SCIENTIFIC PHARMACEUTICALS, INC.
3221 PRODUCER WAY
POMONA, CA 91768-3916 US
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Contact JAN A ORLOWSKI
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Regulation Number 872.3750

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Classification Product Code DYH
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Date Received 05/08/2000
Decision Date 07/21/2000
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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