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FDA 510(k) Application Details - K072707
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
More FDA Info for this Device
510(K) Number
K072707
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
KLS-MARTIN L.P.
11239-1 ST. JOHN'S IND. PKWY.
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
09/25/2007
Decision Date
12/19/2007
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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