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FDA 510(k) Application Details - K150511
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device
510(K) Number
K150511
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
SUN MEDICAL CO., LTD
571-2 FURUTAKA-CHO
MORIYAMA CITY 524-0044 JP
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Contact
MR. YUKIHITO YUKIMUNE
Other 510(k) Applications for this Contact
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
02/27/2015
Decision Date
05/27/2015
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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