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FDA 510(k) Application Details - K964400
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K964400
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
ALPHATEC MFG., INC.
42-160 STATE ST.
PALM DESERT, CA 92211-5148 US
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Contact
KENNETH J KISCO
Other 510(k) Applications for this Contact
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
11/04/1996
Decision Date
04/28/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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