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FDA 510(k) Application Details - K100857
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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510(K) Number
K100857
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
JOHN J RICCIO
44 CHURCH STREET
WEST HAVEN, CT 06516 US
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Contact
JOHN RICCIO
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Regulation Number
888.3030
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Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
03/26/2010
Decision Date
05/27/2010
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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