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FDA 510(k) Application Details - K955388
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
More FDA Info for this Device
510(K) Number
K955388
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant
ACE MEDICAL CO.
2260 EAST EL SEGUNDO BLVD.
LOS ANGELES, CA 90245 US
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Contact
NANCY GIEZEN
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Regulation Number
888.3030
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Classification Product Code
LXT
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More FDA Info for this Product Code
Date Received
11/24/1995
Decision Date
01/31/1996
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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