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FDA 510(k) Application Details - K163579
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K163579
Device Name
Plate, Bone
Applicant
KLS Martin LP
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 US
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Contact
Jennifer Damato
Other 510(k) Applications for this Contact
Regulation Number
872.4760
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Classification Product Code
JEY
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More FDA Info for this Product Code
Date Received
12/20/2016
Decision Date
11/21/2017
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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