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FDA 510(k) Application Details - K033749
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K033749
Device Name
Screw, Fixation, Bone
Applicant
ADVANCED BIOMATERIALS
265 ROUTE DE LA BARONNE
ST. JEANNET 06640 FR
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Contact
PATRICK JANIN
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2003
Decision Date
02/23/2004
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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