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FDA 510(k) Application Details - K160918
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device
510(K) Number
K160918
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
JUVORA
TECHNOLOGY CENTRE, HILLHOUSE INTERNATIONAL
THORNTON-CLEVELEYS FY5 4QD GB
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Contact
SELINA SALTHOUSE
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Regulation Number
872.3760
More FDA Info for this Regulation Number
Classification Product Code
EBI
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More FDA Info for this Product Code
Date Received
04/04/2016
Decision Date
02/13/2017
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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