FDA 510(k) Application Details - K013881

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

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510(K) Number K013881
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant RIBBOND, INC.
1402 3RD AVE., SUITE 1030
SEATTLE, WA 98101-2118 US
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Contact SHOSHANA RUDO DRIVER
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 11/23/2001
Decision Date 01/25/2002
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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