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FDA 510(k) Application Details - K193618
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K193618
Device Name
Orthopedic Stereotaxic Instrument
Applicant
Blue Ortho
6 Allee de Bethleem
Gieres 38610 FR
Other 510(k) Applications for this Company
Contact
Matthieu Coic
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
OLO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2019
Decision Date
09/02/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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