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FDA 510(k) Application Details - K172206
Device Classification Name
More FDA Info for this Device
510(K) Number
K172206
Device Name
NAJAÖ Ligament Correction System
Applicant
Cousin Biotech S.A.S.
8 Rue De L'abbe Bonpain
Wervicq-Sud 59117 FR
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Contact
Mathilde Collet
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Regulation Number
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Classification Product Code
OWI
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More FDA Info for this Product Code
Date Received
07/21/2017
Decision Date
04/10/2018
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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