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FDA 510(k) Application Details - K062857
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
More FDA Info for this Device
510(K) Number
K062857
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
KLS MARTIN L.P.
11239 ST. JOHNS INDUSTRIAL
PARKWAY SOUTH
JACKSONVILLE, FL 32246 US
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Contact
JENNIFER DAMATO
Other 510(k) Applications for this Contact
Regulation Number
882.5330
More FDA Info for this Regulation Number
Classification Product Code
GXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/2006
Decision Date
11/22/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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