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FDA 510(k) Application Details - K132600
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K132600
Device Name
Plate, Bone
Applicant
BIOMET MICROFIXATION
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218 US
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Contact
ELIZABETH WHEELER
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/20/2013
Decision Date
10/02/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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