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FDA 510(k) Application Details - K080590
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
More FDA Info for this Device
510(K) Number
K080590
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
2444 205TH STREET, UNIT 5
TORRANCE, CA 90501 US
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Contact
PAUL DONER
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Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTW
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More FDA Info for this Product Code
Date Received
03/03/2008
Decision Date
05/06/2008
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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