FDA 510(k) Application Details - K071245

Device Classification Name Resin, Denture, Relining, Repairing, Rebasing

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510(K) Number K071245
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant TALON ACRYLICS, INC.
850 N.E. 102ND AVE.
PORTLAND, OR 97220-4007 US
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Contact SHERMAN WATSON
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 05/03/2007
Decision Date 08/02/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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