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FDA 510(k) Application Details - K173039
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K173039
Device Name
Plate, Bone
Applicant
Materialise NV
Technologielaan 15
Leuven 3001 BE
Other 510(k) Applications for this Company
Contact
Lina Ramirez
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
JEY
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More FDA Info for this Product Code
Date Received
09/28/2017
Decision Date
07/10/2018
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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