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FDA 510(k) Application Details - K150780
Device Classification Name
More FDA Info for this Device
510(K) Number
K150780
Device Name
Acetabular Cup Orientation System
Applicant
MATERIALISE NV
TECHNOLOGIELAAN 15
LEUVEN 3001 BE
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Contact
OLIVER CLEMENS
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PLW
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Date Received
03/25/2015
Decision Date
10/27/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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