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FDA 510(k) Application Details - K180249
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K180249
Device Name
Plate, Bone
Applicant
Matrix Surgical Holdings, LLC/Matrix Surgical USA
4025 Welcome All Road
Suite 120
Atlanta, GA 30349 US
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Contact
John O'Shaughnessy
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
01/29/2018
Decision Date
10/11/2018
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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