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FDA 510(k) Application Details - K031034
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
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510(K) Number
K031034
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218 US
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Contact
KIM REED
Other 510(k) Applications for this Contact
Regulation Number
882.5330
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Classification Product Code
GXN
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More FDA Info for this Product Code
Date Received
04/01/2003
Decision Date
05/21/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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