FDA 510(k) Application Details - K170375

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

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510(K) Number K170375
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant CMP Industries LLC
413 N. Pearl St.
Albany, NY 12207 US
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Contact Devon O. Howe
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 02/07/2017
Decision Date 10/02/2017
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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