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FDA 510(k) Application Details - K070823
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K070823
Device Name
Plate, Fixation, Bone
Applicant
BIOMET TRAUMA
100 INTERFACE PARKWAY
PARSIPPANY, NJ 07054 US
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Contact
SUSAN ALEXANDER
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/26/2007
Decision Date
05/07/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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