FDA 510(k) Application Details - K200764

Device Classification Name Cord, Retraction

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510(K) Number K200764
Device Name Cord, Retraction
Applicant Centrix Incorporated
770 River Road
Shelton, CT 06484 US
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Contact Greg Moreau
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Regulation Number 000.0000

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Classification Product Code MVL
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Date Received 03/24/2020
Decision Date 10/15/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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