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FDA 510(k) Application Details - K063052
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K063052
Device Name
Plate, Bone
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
872.4760
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Classification Product Code
JEY
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More FDA Info for this Product Code
Date Received
10/04/2006
Decision Date
01/12/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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