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FDA 510(k) Application Details - K124034
Device Classification Name
More FDA Info for this Device
510(K) Number
K124034
Device Name
MECTALIF ANTERIOR
Applicant
MEDACTA INTERNATIONAL
4725 Calle Quetzal, Unit B
Camarillo, CA 93012 US
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Contact
ADAM GROSS
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Regulation Number
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Classification Product Code
OVD
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Date Received
12/28/2012
Decision Date
05/17/2013
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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