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FDA 510(k) Application Details - K000319
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K000319
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY, NJ 07054 US
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Contact
JONAS WILF
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/02/2000
Decision Date
02/25/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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