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FDA 510(k) Application Details - K071394
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K071394
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
SMALL BONE INNOVATIONS INC.
505 PARK AVE., 14TH FLOOR
NEW YORK, NY 10022 US
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Contact
ROBERT HOEHN
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Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
05/21/2007
Decision Date
06/29/2007
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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